Hematologic MalignanciesPhase 2NCT02988466
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT
A Phase 2 study testing Haplo HCT <55 years old, Haplo HCT ≥55 years old and GVHD Prophylaxis in people with Hematologic Malignancies, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Haplo HCT <55 years old, Haplo HCT ≥55 years old and GVHD Prophylaxis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2017to 24 Mar 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Karnofsky performance status of ≥70% or Lansky play score ≥ 70%
- A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches
- The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1.
- Adequate liver and renal function
- Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
- Diffusion capacity corrected (DLCOcorr) > 40% predicted, and absence of O2 requirements
Show all 10Show fewer
- > 6 months after prior autologous transplant (if applicable)
- Agrees to use contraception during study treatment
- Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
- Patients who are HIV+ must have undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation
Who cannot join
- < 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
- Pregnancy or breastfeeding
- Current active and uncontrolled serious infection
- Acute leukemia in morphologic relapse/persistent disease defined as > 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods).
- CML in blast crisis
- Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy.
Show all 12Show fewer
- stable non-bulky disease is acceptable.
- Active central nervous system malignancy
- Criteria For Donor Selection:
- Donors must be HLA-haploidentical relatives of the patient, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1.
- Eligible donors (14-70 years old) include biological children, siblings or half siblings, or parents, able and willing to undergo bone marrow harvesting.
- For donors <18 years, the maximum recipient weight (actual body weight) should not exceed 1.25 times the donor weight (actual body weight)1 In addition, bone marrow product volume should be limited to 20 ml/kg donor weight for donors <18 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies
This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) >3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D
- Conditions
- Hematologic Malignancies
- Being tested
- Haplo HCT <55 years old, Haplo HCT ≥55 years old, GVHD Prophylaxis, Haplo HCT ≥55 and < 65 years old, Haplo HCT ≥65 and ≤75 years old
- Keywords
- Acute Leukemias, Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL)/lymphoma, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, Myelodysplastic syndrome, Chronic myelogenous leukemia, Minimal Residual Disease (MRD) positive leukemia, Leukemia or Myelodysplastic Syndromes (MDS) in aplasia, Myeloproliferative neoplasms/myelofibrosis, Relapsed large-cell lymphoma, mantle-cell lymphoma and Hodgkin lymphoma, Burkitt's lymphoma, Relapsed T-cell lymphoma, Natural Killer cell malignancies, Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma, Lymphoplasmacytic lymphoma, Relapsed multiple myeloma, Bone marrow failure syndromes
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Neoplasm, Residual, Leukemia, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haplo HCT <55 years oldBiological
Also called HLA-haploidentical related hematopoietic cells transplant
- Fludarabine (Flu)
- Cyclophosphamide (Cy)
- Melphalan (Mel)
- Total body irradiation (TBI)
- Non-T-cell depleted donor bone marrow stem cell infusion Day 0
Haplo HCT ≥55 years oldBiological
Also called HLA-haploidentical related hematopoietic cells transplant
- Fludarabine (Flu)
- Cyclophosphamide (Cy)
- Melphalan (Mel): Dose reduction by 30%
- Total body irradiation (TBI)
- Non-T-cell depleted donor bone marrow stem cell infusion
GVHD ProphylaxisDrug
- Cyclophosphamide (Cy)
- Tacrolimus (Tac)
- Mycophenolate mofetil (MMF)
Haplo HCT ≥55 and < 65 years oldBiological
Also called HLA-haploidentical related hematopoietic cells transplant
- Fludarabine (Flu)
- Cyclophosphamide (Cy)
- Melphalan (Mel)
- Total body irradiation (TBI)
- non-T-cell depleted donor bone marrow stem cells
Haplo HCT ≥65 and ≤75 years oldBiological
Also called HLA-haploidentical related hematopoietic cells transplant
- Fludarabine (Flu)
- Cyclophosphamide (Cy)
- Total body irradiation (TBI)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Haplo-HCT <55 years old | Experimental | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients <55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Receives: Biological: Haplo HCT <55 years old; Drug: GVHD Prophylaxis |
| CLOSED Arm B: Haplo-HCT ≥55 years old | Experimental | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Receives: Biological: Haplo HCT ≥55 years old; Drug: GVHD Prophylaxis |
| Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo | Experimental | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old. Receives: Drug: GVHD Prophylaxis; Biological: Haplo HCT ≥55 and < 65 years old |
| Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3 | Experimental | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Receives: Drug: GVHD Prophylaxis; Biological: Haplo HCT ≥65 and ≤75 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS)
Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant
Measured: 1 year
Secondary outcomes (4)
Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)
Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD).
Measured: day 100
Treatment Related Mortality (TRM)
Percentage of participants experiencing treatment related mortality (TRM).
Measured: 6 month, 1 and 2 year
Relapse Incidence
Percentage of participants experiencing a relapse incidence at 1 and 2 years.
Measured: 1 and 2 year
Incidence of Serious Fungal and Viral Infection
Percentage of participants experiencing incidence of serious fungal and viral infection post-HCT
Measured: at day 100 and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start24 Jan 2017
- Primary completion2 May 2023
- Study completion24 Mar 2025
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 Hematologic MalignanciesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Najla El Jurdi, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988466
- Sponsor's protocol ID
- 2016LS092
- Other IDs
- MT2016-15
- Status last verified
- May 2025
- First submitted
- 7 Dec 2016
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02988466
- Acronym / sponsor ID
- 2016LS092
- Conditions
- Hematologic Malignancies
- Keywords
- Acute Leukemias, Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL)/lymphoma, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, Myelodysplastic syndrome, Chronic myelogenous leukemia, Minimal Residual Disease (MRD) positive leukemia, Leukemia or Myelodysplastic Syndromes (MDS) in aplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Posted 28 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) >3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Haplo-HCT <55 years old | Experimental | Biological: Haplo HCT <55 years old, Drug: GVHD ProphylaxisReduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients <55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 |
| CLOSED Arm B: Haplo-HCT ≥55 years old | Experimental | Biological: Haplo HCT ≥55 years old, Drug: GVHD ProphylaxisReduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. |
| Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo | Experimental | Drug: GVHD Prophylaxis, Biological: Haplo HCT ≥55 and < 65 years oldReduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old. |
| Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3 | Experimental | Drug: GVHD Prophylaxis, Biological: Haplo HCT ≥65 and ≤75 years oldReduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Karnofsky performance status of ≥70% or Lansky play score ≥ 70%
- A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches
- The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1.
- Adequate liver and renal function
- Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
Key exclusion criteria (12 listed)
- < 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
- Pregnancy or breastfeeding
- Current active and uncontrolled serious infection
- Acute leukemia in morphologic relapse/persistent disease defined as > 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods).
- CML in blast crisis
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 |
|---|---|---|
| Haplo HCT <55 years oldAlso: HLA-haploidentical related hematopoietic cells transplant* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 | Biological | Arm A: Haplo-HCT <55 years old |
| Haplo HCT ≥55 years oldAlso: HLA-haploidentical related hematopoietic cells transplant* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion | Biological | CLOSED Arm B: Haplo-HCT ≥55 years old |
| GVHD Prophylaxis* Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) | Drug | Arm A: Haplo-HCT <55 years old, Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo, Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3, CLOSED Arm B: Haplo-HCT ≥55 years old |
| Haplo HCT ≥55 and < 65 years oldAlso: HLA-haploidentical related hematopoietic cells transplant* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells | Biological | Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo |
| Haplo HCT ≥65 and ≤75 years oldAlso: HLA-haploidentical related hematopoietic cells transplant* Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI) | Biological | Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3 |
Primary outcome
Disease-free Survival (DFS)
Time frame: 1 year
Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant
4 secondary outcomes
Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)
Time frame: day 100
Treatment Related Mortality (TRM)
Time frame: 6 month, 1 and 2 year
Relapse Incidence
Time frame: 1 and 2 year
Incidence of Serious Fungal and Viral Infection
Time frame: at day 100 and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hematologic Malignancies
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
Najla El Jurdi, 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 Haplo HCT <55 years old, Haplo HCT ≥55 years old and GVHD Prophylaxis in people with Hematologic Malignancies, 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 10 inclusion and 12 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 28 May 2025. 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 28 May 2025). 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?
Disease-free Survival (DFS) (time frame: 1 year). 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 May 2025.