Clinical trial · Interventional
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies
NCT02988466CI-TRIAL-00090220completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GVHD Prophylaxis | Drug | — | UNRESOLVED |
| Haplo HCT ≥55 and < 65 years old | Biological | — | UNRESOLVED |
| Haplo HCT <55 years old | Biological | — | UNRESOLVED |
| Haplo HCT ≥65 and ≤75 years old | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A: Haplo-HCT <55 years old
- description
- 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
- interventionNames
- Biological: Haplo HCT <55 years old
- Drug: GVHD Prophylaxis
- type
- EXPERIMENTAL
- label
- CLOSED Arm B: Haplo-HCT ≥55 years old
- description
- 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.
- interventionNames
- Biological: Haplo HCT ≥55 years old
- Drug: GVHD Prophylaxis
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * \> 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 Exclusion Criteria: * \< 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. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.