LeukemiaPhase 2NCT00871689
Chemotherapy, Total-Body Irradiation, Donor Natural Killer Cell Infusion, Aldesleukin, and UCB Transplant in Treating Patients With Relapsed or Refractory AML
A Phase 2 study testing aldesleukin, cyclophosphamide and fludarabine phosphate in people with Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Read more about this study
- Who is it for?
- Ages Up to 45 years
- Conditions the study is for
- Leukemia
- What is being tested?
- aldesleukin, cyclophosphamide and fludarabine phosphate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Oct 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 0 to 45 years who meet one of the following criteria:
- Primary induction failure defined as no complete remission (CR) after two or three induction cycles (no blast limit).
- Relapsed acute myeloid leukemia (AML) with low disease burden
- For patients 19 through 45 years of age: must have less than 10% marrow blasts at time of enrollment for patients who did not receive re-induction or measured at least 28 days from the start of re-induction therapy. Patients who have relapsed more than 12 months following a prior hematopoietic cell transplant (HCT) and did not reach CR following one re-induction cycle but have less than 10% marrow blasts are eligible.
- For patients 0 through 18 years of age: must have less than 50% marrow blasts after no more than 3 induction attempts
- CR3 or greater. This will include CRp defined as CR without platelet recovery to 100,000/mcL.
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- CR1 or CR2 with high risk features (therapy induced, prior myelodysplastic syndrome (MDS) or myeloproliferative disease (MPD), high risk cytogenetic or molecular phenotype) with no available alternate (sibling, URD or UCB) donors.
- Patients with prior central nervous system (CNS) involvement are eligible provided that it has been treated and is in remission. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the protocol.
- Have acceptable organ function within 14 days of enrollment defined as:
- Renal: creatinine ≤ 2.0 mg/dL (adult patients) or calculated creatinine clearance > 40 ml/min (pediatric patients)
- Hepatic: bilirubin, AST/ALT, ALP ≤ 5 x upper limit of normal
- Pulmonary function: DLCOcorr > 50% of normal, (oxygen saturation [>92%] can be used in child where PFT's cannot be obtained)
- Cardiac: left ventricular ejection fraction ≥ 45%
- Karnofsky score (adults) > 70% or Lansky score > 50% (pediatrics)
- Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment.
- All patients will be questioned about prior exposure to antibody therapy (including OKT3, rituximab, trastuzumab, and gemtuzumab) without affect to eligibility. Patients with prior exposure will have a blood sample collected for human anti-mouse antibody (HAMA). For patients with no prior antibody therapy exposure, no further action will be taken.
- Not receiving prednisone or other immunosuppressive medications
- Voluntary written consent
Who cannot join
- Active infection at time of enrollment or documented fungal infection within 3 months
- Evidence of HIV infection or known HIV positive serology
- Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
- If ≤ 18 years old, prior myeloablative transplant within the last 6 months. If > 18 years old prior myeloablative allotransplant or autologous transplant
- Extensive prior therapy including > 12 months of any alkylator chemotherapy (etoposide >100 mg/m^2 x 5 days, cyclophosphamide >1 gm/m^2 or mitoxantrone >8 gm/m^2) delivered at 3-4 week intervals or > 6 months alkylator therapy (as above) with extensive radiation (determined by Radiation Oncology, e.g. mantle irradiation for Hodgkin's) and/or prior radiation therapy that makes a patient ineligible for total body irradiation (TBI).
- Criteria for Second Course of IL-2 (begin day +60):
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- No Graft-Versus-Host Disease (GVHD), active infection or any other severe medical co-morbidity
- Absolute neutrophil count (ANC) > 1000 without growth factor support
- No grade 4 toxicity (except fevers) attributed to IL-2 during course #1
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, 55455
About this study
Official title: Haploidentical Donor NK Cell Adoptive Therapy and Double T Cell Depleted Umbilical Cord Blood Transplantation With Post-Transplant IL-2 Immune Therapy For Refractory Acute Myeloid Leukemia
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving interleukin-2 (IL-2, aldesleukin) after transplant may stimulate the natural killer cells to kill any remaining cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with total-body irradiation followed by interleukin-2 (IL-2, aldesleukin), and umbilical cord blood transplant and to see how well it works in treating patients with relapsed or refractory acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
Primary
- To determine the rate of neutrophil engraftment and grade III-IV acute graft-versus-host disease (GVHD) following a T cell depleted (TCD) umbilical cord blood (UCB) transplantation without post-transplant immunosuppression followed by administration of interleukin-2 (IL-2, aldesleukin) (every other day) days +3 to +13 to expand NK cells in vivo.
Secondary
- To evaluate the safety of this regimen as assessed by monitoring the rates of graft failure, acute GVHD, and transplant-related mortality (TRM).
- To perform quantitative, phenotypic, and functional assessments of the in vivo expanded UCB-derived NK cells on (day +72).
- To assess clinical disease response (leukemia clearance and complete remission) and survival duration in these patients.
- To evaluate the tolerability of aldesleukin in these patients.
- To evaluate the tolerance of IL-2
OUTLINE:
- Preparative regimen: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -7 to -5 and cyclophosphamide IV on days -7 and -6. Patients undergo total-body irradiation twice daily on days -5 to -2.
- Transplantation: Patients undergo T-cell depleted umbilical cord blood (UCB) transplantation on day 0.
- IL-2 (Aldesleukin) therapy: Patients receive aldesleukin subcutaneously on days +3 6 doses every other day) and +60 (6 doses every other day).
Patients are followed periodically for up to 2 years after transplant.
- Conditions
- Leukemia
- Being tested
- aldesleukin, cyclophosphamide, fludarabine phosphate, umbilical cord blood transplantation, total-body irradiation
- Keywords
- recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent childhood acute myeloid leukemia, secondary acute myeloid leukemia, childhood acute myeloid leukemia with 11q23 (MLL) abnormalities, childhood acute myeloid leukemia with inv(16)(p13;q22), childhood acute myeloid leukemia with t(15;17)(q22;q12), childhood acute myeloid leukemia with t(16;16)(p13;q22), childhood acute myeloid leukemia with t(8;21)(q22;q22)
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
Also called IL-2, interleukin-2
IL-2 will be administered (9 million units; 5 million units if weight is less than 45 kg) every other day beginning on day +3 for a total of 6 doses and again on day +60 every other day for 6 doses.
cyclophosphamideDrug
Also called Cytoxan
60 mg/kg over 1 hour intravenously (IV) on days -7 and -6.
Also called Fludarabine, Fludara
25 mg/m^2 intravenously (IV) over 1 hour on days -7 through -5.
umbilical cord blood transplantationProcedure or surgery
Also called UCBT
On day 0, transplantation will occur with double T-cell depleted (TCD) umbilical cord blood (UCB) units
total-body irradiationRadiation
Also called TBI
administered on days -5 through -2; 330 cGy daily
| Study group | Role | What they receive |
|---|---|---|
| UCBT With Post-Transplant IL-2 | Experimental | Patients receive cyclophosphamide, fludarabine phosphate, total-body irradiation, T cell depleted umbilical cord blood transplantation (UCBT), followed by interleukin-2 (IL-2, aldesleukin) every other day beginning day +3 for a total of 6 doses and again on day +60 every other day for 6 doses. Receives: Biological: aldesleukin; Drug: cyclophosphamide; Drug: fludarabine phosphate; Procedure: umbilical cord blood transplantation; Radiation: total-body irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Neutrophil Engraftment
Number of patient with absolute neutrophils >500*10^8/kg by 42 days post transplant.
Measured: Day 42
Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease
Number of patients with Grade III-IV GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.
Acute GVHD usually happens within the first 3 months after transplant.
Measured: Day 100 Post Transplant
Secondary outcomes (6)
Incidence of Primary Graft Failure
Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) on day 42.
Measured: Day 42
Number of Patients With Acute Graft-Versus-Host (GVHD) Disease
Number of patients with any grade of GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.
Acute GVHD usually happens within the first 3 months after transplant.
Measured: Day 100 Post Transplant
Number of Patients With Transplant-Related Death (TRD)
Number of patients whose death is related to study treatment received. TRD is defined as the number of patients that die without prior relapse.
Measured: 1 Year Post Transplant
Number of Patients With Complete Remission of Disease
Disease response will be measured by rate of leukemic clearance (clearance of blasts in blood at timepoint 0) and complete remission (less than 5% blasts and recovery of hematopoiesis).
Measured: Day 100
Median Overall Survival
Average number of days the patients were alive after receiving UCB transplantation.
Measured: Month 6
Number of Patients With Successful Natural Killer Expansion
Successful in vivo donor NK cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl.
Measured: Day 72 Post Transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionOct 2011
Why it stopped: Due to graft failure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael R. Verneris, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871689
- Sponsor's protocol ID
- 2008LS110
- Other IDs
- MT2008-36, 0810M51781
- Status last verified
- Dec 2017
- First submitted
- 27 Mar 2009
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haploidentical Donor NK Cell Adoptive Therapy and Double T Cell Depleted Umbilical Cord Blood Transplantation With Post-Transplant IL-2 Immune Therapy For Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00871689
- Acronym / sponsor ID
- 2008LS110
- Conditions
- Leukemia
- Keywords
- recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent childhood acute myeloid leukemia, secondary acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to graft failure.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Posted 16 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving interleukin-2 (IL-2, aldesleukin) after transplant may stimulate the natural killer cells to kill any remaining cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with total-body irradiation followed by interleukin-2 (IL-2, aldesleukin), and umbilical cord blood transplant and to see how well it works in treating patients with relapsed or refractory acute myeloid leukemia.
Detailed description
OBJECTIVES:
Primary
- To determine the rate of neutrophil engraftment and grade III-IV acute graft-versus-host disease (GVHD) following a T cell depleted (TCD) umbilical cord blood (UCB) transplantation without post-transplant immunosuppression followed by administration of interleukin-2 (IL-2, aldesleukin) (every other day) days +3 to +13 to expand NK cells in vivo.
Secondary
- To evaluate the safety of this regimen as assessed by monitoring the rates of graft failure, acute GVHD, and transplant-related mortality (TRM).
- To perform quantitative, phenotypic, and functional assessments of the in vivo expanded UCB-derived NK cells on (day +72).
- To assess clinical disease response (leukemia clearance and complete remission) and survival duration in these patients.
- To evaluate the tolerability of aldesleukin in these patients.
- To evaluate the tolerance of IL-2
OUTLINE:
- Preparative regimen: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -7 to -5 and cyclophosphamide IV on days -7 and -6. Patients undergo total-body irradiation twice daily on days -5 to -2.
- Transplantation: Patients undergo T-cell depleted umbilical cord blood (UCB) transplantation on day 0.
- IL-2 (Aldesleukin) therapy: Patients receive aldesleukin subcutaneously on days +3 6 doses every other day) and +60 (6 doses every other day).
Patients are followed periodically for up to 2 years after transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCBT With Post-Transplant IL-2 | Experimental | Biological: aldesleukin, Drug: cyclophosphamide, Drug: fludarabine phosphate, Procedure: umbilical cord blood transplantation, Radiation: total-body irradiationPatients receive cyclophosphamide, fludarabine phosphate, total-body irradiation, T cell depleted umbilical cord blood transplantation (UCBT), followed by interleukin-2 (IL-2, aldesleukin) every other day beginning day +3 for a total of 6 doses and again on day +60 every other day for 6 doses. |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- Aged 0 to 45 years who meet one of the following criteria:
- Patients with prior central nervous system (CNS) involvement are eligible provided that it has been treated and is in remission. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the protocol.
- Have acceptable organ function within 14 days of enrollment defined as:
- Karnofsky score (adults) > 70% or Lansky score > 50% (pediatrics)
- Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment.
Key exclusion criteria (9 listed)
- Active infection at time of enrollment or documented fungal infection within 3 months
- Evidence of HIV infection or known HIV positive serology
- Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
- If ≤ 18 years old, prior myeloablative transplant within the last 6 months. If > 18 years old prior myeloablative allotransplant or autologous transplant
- Extensive prior therapy including > 12 months of any alkylator chemotherapy (etoposide >100 mg/m^2 x 5 days, cyclophosphamide >1 gm/m^2 or mitoxantrone >8 gm/m^2) delivered at 3-4 week intervals or > 6 months alkylator therapy (as above) with extensive radiation (determined by Radiation Oncology, e.g. mantle irradiation for Hodgkin's) and/or prior radiation therapy that makes a patient ineligible for total body irradiation (TBI).
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 |
|---|---|---|
| aldesleukinAlso: IL-2, interleukin-2IL-2 will be administered (9 million units; 5 million units if weight is less than 45 kg) every other day beginning on day +3 for a total of 6 doses and again on day +60 every other day for 6 doses. | Biological | UCBT With Post-Transplant IL-2 |
| cyclophosphamideAlso: Cytoxan60 mg/kg over 1 hour intravenously (IV) on days -7 and -6. | Drug | UCBT With Post-Transplant IL-2 |
| fludarabine phosphateAlso: Fludarabine, Fludara25 mg/m^2 intravenously (IV) over 1 hour on days -7 through -5. | Drug | UCBT With Post-Transplant IL-2 |
| umbilical cord blood transplantationAlso: UCBTOn day 0, transplantation will occur with double T-cell depleted (TCD) umbilical cord blood (UCB) units | Procedure or surgery | UCBT With Post-Transplant IL-2 |
| total-body irradiationAlso: TBIadministered on days -5 through -2; 330 cGy daily | Radiation | UCBT With Post-Transplant IL-2 |
Primary outcome
Number of Patients With Neutrophil Engraftment
Time frame: Day 42
Number of patient with absolute neutrophils >500*10^8/kg by 42 days post transplant.
Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease
Time frame: Day 100 Post Transplant
Number of patients with Grade III-IV GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Acute GVHD usually happens within the first 3 months after transplant.
6 secondary outcomes
Incidence of Primary Graft Failure
Time frame: Day 42
Number of Patients With Acute Graft-Versus-Host (GVHD) Disease
Time frame: Day 100 Post Transplant
Number of Patients With Transplant-Related Death (TRD)
Time frame: 1 Year Post Transplant
Number of Patients With Complete Remission of Disease
Time frame: Day 100
Median Overall Survival
Time frame: Month 6
Number of Patients With Successful Natural Killer Expansion
Time frame: Day 72 Post Transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael R. Verneris, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aldesleukin, cyclophosphamide and fludarabine phosphate in people with Leukemia, run by Masonic Cancer Center, University of Minnesota 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 18 inclusion and 9 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: stopped early, as of the sponsor's last update on 28 Dec 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Neutrophil Engraftment (time frame: Day 42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2017.