Acute Lymphoblastic Leukemia (ALL)Phase 1NCT02226861
Ultra-Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation
A Phase 1 study testing CliniMACS CD34 selection system and ULD IL-2 in people with Acute Lymphoblastic Leukemia (ALL) and Acute Myelogenous Leukemia (AML), run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations. Objective: To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Lymphocytic Leukemia (CLL)
- What is being tested?
- CliniMACS CD34 selection system and ULD IL-2
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2014to 27 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-70 years inclusive
- Haploidentical donor available
- Any one of the following hematologic conditions meeting a standard indication for allogeneic stem cell transplant:
- Chronic myelogenous leukemia (CML): Subjects under the age of 21 in chronic phase OR subjects ages 18-65 in chronic phase who have failed treatment with imatinib or have intolerance to imatinib OR Subjects ages 18-65 in accelerated phase or blast transformation. OR
- Acute lymphoblastic leukemia (ALL): any of these categories: Adult ALL including standard risk. All second or subsequent remissions, primary induction failure, partially responding or untreated relapse. OR
- Acute myelogenous leukemia (AML): AML in first remission - except AML with good risk karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), c-kit unmutated AML t (8; 21). All AML in second or subsequent remission, primary induction failure and resistant relapse. OR
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- Myelodysplasticsyndromes(MDS): any of these categories - refractory anemia with transfusion dependence, refractory anemia with ANC<500/ (Micro)L, refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia, atypical MDS/myeloproliferative syndromes. OR
- Myeloproliferative disorders including atypical (Ph-negative) chronic myeloid and neutrophilic leukemias, progressing myelofibrosis, and polycythemia vera, essential thrombocythemia either in transformation to acute leukemia or with progressive transfusion requirements or pancytopenia. OR
- Non-Hodgkin s lymphoma including Mantle cell lymphoma relapsing or refractory to standard of care treatments. OR
- Multiple myeloma, Waldenstroms macroglobulinemia, unresponsive or relapsed following standard of care treatments. OR
- Hodgkin's Lymphoma relapsing following an autologous transplant. OR
- Other rare hematologic malignancies for which hematopoietic stem cell transplantation has been performed and offers a durable remission or as the only option with a potential for cure.
- Chemotherapy-resistant multisystem Langerhans cell histiocytosis (MSLCH) especially involving organs like the bone marrow, liver, spleen, and lungs
- Aggressive systemic mastocytosis, and mast cell leukemia (MCL) in first CR (CR1)
- Hypereosinophilic syndrome who have failed imatinib therapy or FIP1L1-PDGFRa-negative patients who develop end-organ dysfunction
- Adult T-cell leukemia/lymphoma at first diagnosis
- Refractory or disseminated nasal-type extranodal NK/T-lymphoma or aggressive Natural killer cell leukemia/lymphoma
- Mycosis fungoides and S(SqrRoot)(Copyright)zary syndrome after failure of two or three initial therapies
- Primary or relapsed refractory Angioimmunoblastic T-cell lymphoma at first diagnosis
- Hepatosplenic T-cell lymphoma (gamma/delta T-cell lymphoma) at first diagnosis
- T-cell prolymphocytic leukemia at first diagnosis
- Subcutaneous panniculitic T-cell lymphoma at first diagnosis
- Hematodermic neoplasm (blastic natural killer cell lymphoma or Blastic plasmacytoid dendritic cell neoplasm) at first diagnosis
- Ability to comprehend the investigational nature of the study and provide informed consent.
- Related donor who shares 1 haplotype with the recipient
- Age greater than or equal to 18 or less than or equal to 80 years old
- Ability to comprehend the investigational nature of the study and provide informed consent.
Who cannot join
- HLA identical (6/6) related or (8/8 allele level matched) unrelated donor available and readily accessible at time of transplantation evaluation
- Major anticipated illness or organ failure incompatible with survival from transplant
- Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and making informed consent impossible.
- Positive pregnancy test for women of childbearing age
- Contraindication to receive IL-2 including:
- Hypersensitivity to IL-2
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- Sustained ventricular tachycardia (>5 beats)
- Cardiac arrhythmias not controlled or unresponsive to management
- Chest pain with ECG changes, consistent with angina or myocardial infarction
- Cardiac tamponade
- Intubation for >72 hours
- Renal failure requiring dialysis >72 hours
- Coma or toxic psychosis lasting > 48 hours
- Repetitive or difficult to control seizures
- Active bowel ischemia or perforation
- Active GI bleeding requiring surgery
- DLCO adjusted for Hb and ventilation< 50% predicted
- Left ventricular ejection fraction < 40% (evaluated by ECHO) or < 30% (evaluated by MUGA)
- AST/SGOT > 5 times ULN
- Total bilirubin > 3 times ULN
- Estimated GFR <60ml/min (calculated by CKD-EPI, a formula routinely used in Clinical Research Center at National Institutes of Health. In case of borderline estimated GFR, CKD-EPI creatinine-cystatin C formula will be used for more accurate estimation)
- Prior allogeneic stem cell transplantation
- Unfit to receive G-CSF and undergo apheresis such as abnormal blood counts, history of stroke, uncontrolled hypertension
- Sickling hemaglobinopathy including HbSS, HbAS, HbSC
- Donors who are positive for HIV, active hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II)
- Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Ultra Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation
Background:
- Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations.
Read more
Objective:
- To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD.
Eligibility:
- Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an available family member with partial tissue match.
- Donors: age 18 80.
Design:
- Recipients will be screened with medical history, physical exam, and many tests including blood and tissue tying.
- Donors will be screened with medical history, physical exam, blood tests and tissue typing.
- Recipients will stay in the hospital 3 6 weeks.
- All participants will have apheresis. Blood is drawn from one arm, run through a machine that collects white blood cells, then returned into the other arm.
- Recipients will have:
- Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout transplant and recovery. They may also have a catheter inserted for collecting immune cells.
- Bone marrow sample taken by needle. They will have 3 more after transplant.
- Donors will have:
- Filgrastim injected once daily for 5 6 days.
- Stem and immune cells collected by another apheresis.
- Recipients will get:
- Eight 30-minute doses of radiation, sitting at a machine.
- Donor immune cells by IV, 6 days before the transplant day.
- Chemotherapy drugs by IV.
<TAB><TAB>- Donor stem cells by IV on transplant day.
- After transplant, recipients will give self-injections of very low doses of Interleukin-2 once daily for about 12 weeks.
- Before and after transplant, recipients will get medicine to suppress the immune system and antibiotics to prevent infections
- Recipients must stay near NIH for 3 6 months after transplant.
- All recipients and donors will have 3 years of follow-up.
Read the detailed description
Although allogeneic stem cell transplantation (allo-SCT) is a curative option for many hematologic malignancies, not all have a suitable donor. Haploidentical peripheral blood stem cell transplantation (haplo-SCT) has the advantage of immediate availability, higher stem cell dose, and feasibility of repeated cell collections for generating lymphocyte infusions to treat or prevent relapse or infection. However, haplo-SCT incurs a risk of bidirectional rejection with either severe graft versus host disease (GVHD) or graft rejection by the recipient. Therefore it is important to develop novel strategies to optimize the outcome of haplo-SCT. Designing a haplo-SCT that incorporates the concepts of modulating the immune system and allowing the opportunity for graft manipulation and/or adoptive immunotherapy may improve the treatment outcome. To achieve this, we are first interested in studying the immune modulatory effect of ultra-low dose Interleukin 2 (ULD IL-2) as GVHD prophylaxis.
This is an investigator initiated pilot study to determine the safety and feasibility of ULD IL-2 as GVHD prophylaxis in haploidentical allogeneic stem cell transplantation for patients with hematologic malignancies. Because GVHD has previously been associated with low numbers of circulating CD4+ CD25+FOXP3+ regulatory T cells (T(regs)), research efforts in increasing T(regs) either ex-vivo with adoptive transfer of T(regs) or in vivo using immunomodulatory agents such as IL-2, have shown promise in reducing incidences of GVHD.
The primary objective of this study is to evaluate safety and feasibility. Secondary objectives are to determine the incidences of acute and chronic GVHD, engraftment, overall survival, transplant related mortality, and relapse.
We will adopt the 2 step haplo-SCT method developed by Grosso et. al1 to study our method of GVHD prophylaxis. This 2 step approach, in which the lymphoid and myeloid portions of the graft are given in two separate steps in order to control and optimize T-cell, has already been published as a feasible and safe platform for haplo SCT for patients with hematologic malignancies and has been adopted by the Jefferson University Hospital (PA, USA), where they continue to treat patients under this protocol. As an additional GVHD prophylaxis, we will use sirolimus, an previously established GVHD prophylaxis which may work with ULD IL-2 synergistically to increase T(regs) .
The haploidentical donor will be mobilized by G-CSF and undergo one apheresis to collect lymphocytes and CD34+ stem cell product after Miltenyi CD34+ selection. The products will be cryopreserved until the time of transplantation. Recipients will receive a myeloablative conditioning regimen of fludarabine and total body irradiation (TBI) on days -10 to -6. After the last fraction of TBI, a donor lymphocyte infusion (DLI) product (2 times 10(8) CD3+/kg) will be given. Cyclophosphamide will be given on days -3 and -2, followed by CD 34+ selected donor stem cell product infused on day 0. Sirolimus will be initiated on day -1 until day+60. ULD-IL2 (100,000 IU/m2) will give subcutaneously daily for 12 weeks starting day +1.
This study will evaluate 14 recipients (ages greater than or equal to 18 - less than or equal to 75; planned accrual up to 20 recipient in event of replacement) with hematologic malignancies meeting indication for transplant but who do not have matched related or unrelated donor available. Safety will be monitored continuously with a stopping rule for toxicity based on the treatment-related serious adverse event rate (TRSAE). Safety monitoring will continue until at least 114 days after transplantation, and recipients experiencing adverse events will be monitored until toxicity resolution or stabilization. Stopping rule is defined as nonrelapse mortality and steroid refractory GVHD during the period of safety monitoring for ULD IL-2. Recipients will be followed for up to 1 year to evaluate the incidences of acute and chronic GVHD, engraftment, overall survival, transplant related mortality, and relapse.
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Lymphocytic Leukemia (CLL), Chronic Myelogenous Leukemia (CML), MDS
- Being tested
- CliniMACS CD34 selection system, ULD IL-2
- Keywords
- Acute Lymphoblastic Leukemia (ALL), MDS, Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Acute Myelogenous Leukemia (AML)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliniMACS CD34 selection systemDevice
Stem cells will be selected with the CliniMACS system before transplant.
ULD IL-2Biological
sterile, white to off-white, preservative-free, lyophilized powder suitable for IV infusion upon reconstitution and dilution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects will receive CD34-selected stem cells followed by fixed dose ULG IL-2 (100,000 IU/m2) given subcutaneously for 12 weeks+Sirolimus until Day +60 Receives: Device: CliniMACS CD34 selection system; Biological: ULD IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ULD IL-2 as GVHD proph
The primary endpoint to this study is to evaluate the safety of ULD IL-2 as GVHD prophylaxis in haploidentical transplantation.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study start26 Aug 2014
- Primary completion23 May 2018
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia (ALL)Studies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sawa Ito, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226861
- Sponsor's protocol ID
- 140180
- Other IDs
- 14-H-0180
- Status last verified
- 27 Jun 2018
- First submitted
- 26 Aug 2014
- Last updated
- 5 Jul 2018
- Results posted
- No
Publications
Grosso D, Carabasi M, Filicko-O'Hara J, Kasner M, Wagner JL, Colombe B, Cornett Farley P, O'Hara W, Flomenberg P, Werner-Wasik M, Brunner J, Mookerjee B, Hyslop T, Weiss M, Flomenberg N. A 2-step approach to myeloablative haploidentical stem cell transplantation: a phase 1/2 trial performed with optimized T-cell dosing. Blood. 2011 Oct 27;118(17):4732-9. doi: 10.1182/blood-2011-07-365338. Epub 2011 Aug 25.
PubMed 21868572Barrett J, Gluckman E, Handgretinger R, Madrigal A. Point-counterpoint: haploidentical family donors versus cord blood transplantation. Biol Blood Marrow Transplant. 2011 Jan;17(1 Suppl):S89-93. doi: 10.1016/j.bbmt.2010.10.024. No abstract available.
PubMed 21195317Fuchs EJ. Haploidentical transplantation for hematologic malignancies: where do we stand? Hematology Am Soc Hematol Educ Program. 2012;2012:230-6. doi: 10.1182/asheducation-2012.1.230.
PubMed 23233586
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02226861
- Acronym / sponsor ID
- 140180
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Lymphocytic Leukemia (CLL), Chronic Myelogenous Leukemia (CML), MDS
- Keywords
- Acute Lymphoblastic Leukemia (ALL), MDS, Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Acute Myelogenous Leukemia (AML)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 26 Aug 2014
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations.
Objective:
- To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD.
Eligibility:
- Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an available family member with partial tissue match.
- Donors: age 18 80.
Design:
- Recipients will be screened with medical history, physical exam, and many tests including blood and tissue tying.
- Donors will be screened with medical history, physical exam, blood tests and tissue typing.
- Recipients will stay in the hospital 3 6 weeks.
- All participants will have apheresis. Blood is drawn from one arm, run through a machine that collects white blood cells, then returned into the other arm.
- Recipients will have:
- Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout transplant and recovery. They may also have a catheter inserted for collecting immune cells.
- Bone marrow sample taken by needle. They will have 3 more after transplant.
- Donors will have:
- Filgrastim injected once daily for 5 6 days.
- Stem and immune cells collected by another apheresis.
- Recipients will get:
- Eight 30-minute doses of radiation, sitting at a machine.
- Donor immune cells by IV, 6 days before the transplant day.
- Chemotherapy drugs by IV.
<TAB><TAB>- Donor stem cells by IV on transplant day.
- After transplant, recipients will give self-injections of very low doses of Interleukin-2 once daily for about 12 weeks.
- Before and after transplant, recipients will get medicine to suppress the immune system and antibiotics to prevent infections
- Recipients must stay near NIH for 3 6 months after transplant.
- All recipients and donors will have 3 years of follow-up.
Detailed description
Although allogeneic stem cell transplantation (allo-SCT) is a curative option for many hematologic malignancies, not all have a suitable donor. Haploidentical peripheral blood stem cell transplantation (haplo-SCT) has the advantage of immediate availability, higher stem cell dose, and feasibility of repeated cell collections for generating lymphocyte infusions to treat or prevent relapse or infection. However, haplo-SCT incurs a risk of bidirectional rejection with either severe graft versus host disease (GVHD) or graft rejection by the recipient. Therefore it is important to develop novel strategies to optimize the outcome of haplo-SCT. Designing a haplo-SCT that incorporates the concepts of modulating the immune system and allowing the opportunity for graft manipulation and/or adoptive immunotherapy may improve the treatment outcome. To achieve this, we are first interested in studying the immune modulatory effect of ultra-low dose Interleukin 2 (ULD IL-2) as GVHD prophylaxis.
This is an investigator initiated pilot study to determine the safety and feasibility of ULD IL-2 as GVHD prophylaxis in haploidentical allogeneic stem cell transplantation for patients with hematologic malignancies. Because GVHD has previously been associated with low numbers of circulating CD4+ CD25+FOXP3+ regulatory T cells (T(regs)), research efforts in increasing T(regs) either ex-vivo with adoptive transfer of T(regs) or in vivo using immunomodulatory agents such as IL-2, have shown promise in reducing incidences of GVHD.
The primary objective of this study is to evaluate safety and feasibility. Secondary objectives are to determine the incidences of acute and chronic GVHD, engraftment, overall survival, transplant related mortality, and relapse.
We will adopt the 2 step haplo-SCT method developed by Grosso et. al1 to study our method of GVHD prophylaxis. This 2 step approach, in which the lymphoid and myeloid portions of the graft are given in two separate steps in order to control and optimize T-cell, has already been published as a feasible and safe platform for haplo SCT for patients with hematologic malignancies and has been adopted by the Jefferson University Hospital (PA, USA), where they continue to treat patients under this protocol. As an additional GVHD prophylaxis, we will use sirolimus, an previously established GVHD prophylaxis which may work with ULD IL-2 synergistically to increase T(regs) .
The haploidentical donor will be mobilized by G-CSF and undergo one apheresis to collect lymphocytes and CD34+ stem cell product after Miltenyi CD34+ selection. The products will be cryopreserved until the time of transplantation. Recipients will receive a myeloablative conditioning regimen of fludarabine and total body irradiation (TBI) on days -10 to -6. After the last fraction of TBI, a donor lymphocyte infusion (DLI) product (2 times 10(8) CD3+/kg) will be given. Cyclophosphamide will be given on days -3 and -2, followed by CD 34+ selected donor stem cell product infused on day 0. Sirolimus will be initiated on day -1 until day+60. ULD-IL2 (100,000 IU/m2) will give subcutaneously daily for 12 weeks starting day +1.
This study will evaluate 14 recipients (ages greater than or equal to 18 - less than or equal to 75; planned accrual up to 20 recipient in event of replacement) with hematologic malignancies meeting indication for transplant but who do not have matched related or unrelated donor available. Safety will be monitored continuously with a stopping rule for toxicity based on the treatment-related serious adverse event rate (TRSAE). Safety monitoring will continue until at least 114 days after transplantation, and recipients experiencing adverse events will be monitored until toxicity resolution or stabilization. Stopping rule is defined as nonrelapse mortality and steroid refractory GVHD during the period of safety monitoring for ULD IL-2. Recipients will be followed for up to 1 year to evaluate the incidences of acute and chronic GVHD, engraftment, overall survival, transplant related mortality, and relapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CliniMACS CD34 selection system, Biological: ULD IL-2Subjects will receive CD34-selected stem cells followed by fixed dose ULG IL-2 (100,000 IU/m2) given subcutaneously for 12 weeks+Sirolimus until Day +60 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Ages 18-70 years inclusive
- Haploidentical donor available
- Any one of the following hematologic conditions meeting a standard indication for allogeneic stem cell transplant:
- Related donor who shares 1 haplotype with the recipient
- Age greater than or equal to 18 or less than or equal to 80 years old
Key exclusion criteria (26 listed)
- HLA identical (6/6) related or (8/8 allele level matched) unrelated donor available and readily accessible at time of transplantation evaluation
- Major anticipated illness or organ failure incompatible with survival from transplant
- Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and making informed consent impossible.
- Positive pregnancy test for women of childbearing age
- Contraindication to receive IL-2 including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CliniMACS CD34 selection systemStem cells will be selected with the CliniMACS system before transplant. | Device | 1 |
| ULD IL-2sterile, white to off-white, preservative-free, lyophilized powder suitable for IV infusion upon reconstitution and dilution | Biological | 1 |
Primary outcome
Safety of ULD IL-2 as GVHD proph
Time frame: 4 months
The primary endpoint to this study is to evaluate the safety of ULD IL-2 as GVHD prophylaxis in haploidentical transplantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Background: PubMed 21868572Grosso D, Carabasi M, Filicko-O'Hara J, Kasner M, Wagner JL, Colombe B, Cornett Farley P, O'Hara W, Flomenberg P, Werner-Wasik M, Brunner J, Mookerjee B, Hyslop T, Weiss M, Flomenberg N. A 2-step approach to myeloablative haploidentical stem cell transplantation: a phase 1/2 trial performed with optimized T-cell dosing. Blood. 2011 Oct 27;118(17):4732-9. doi: 10.1182/blood-2011-07-365338. Epub 2011 Aug 25.
- Background: PubMed 21195317Barrett J, Gluckman E, Handgretinger R, Madrigal A. Point-counterpoint: haploidentical family donors versus cord blood transplantation. Biol Blood Marrow Transplant. 2011 Jan;17(1 Suppl):S89-93. doi: 10.1016/j.bbmt.2010.10.024. No abstract available.
- Background: PubMed 23233586Fuchs EJ. Haploidentical transplantation for hematologic malignancies: where do we stand? Hematology Am Soc Hematol Educ Program. 2012;2012:230-6. doi: 10.1182/asheducation-2012.1.230.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sawa Ito, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CliniMACS CD34 selection system and ULD IL-2 in people with Acute Lymphoblastic Leukemia (ALL) and Acute Myelogenous Leukemia (AML), run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of ULD IL-2 as GVHD proph (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02226861, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.