Clinical trial · Interventional
Sibling Donor Peripheral Stem Cell Transplant or Sibling Donor Bone Marrow Transplant in Treating Patients With Hematologic Cancers or Other Diseases
A Randomized Multicentre Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation for Hematologic Malignancies
- 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)
RATIONALE: Giving chemotherapy before a donor peripheral stem cell transplant or bone marrow transplant using stem cells from a brother or sister that closely match the patient's stem cells, helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored. Giving methotrexate and cyclosporine before and after transplant may stop this from happening. It is not yet known whether a donor peripheral stem cell transplant is more effective than a donor bone marrow transplant in treating hematologic cancers or other diseases. PURPOSE: This randomized phase III trial is studying filgrastim-mobilized sibling donor peripheral stem cell transplant to see how well it works compared with sibling donor bone marrow transplant in treating patients with hematologic cancers or other diseases.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Secondary Myelofibrosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients undergo filgrastim (G-CSF)-mobilized sibling donor peripheral blood SCT on day 0.
- interventionNames
- Biological: filgrastim
- Procedure: peripheral blood stem cell transplantation
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo G-CSF-mobilized sibling donor bone marrow transplantation on day 0.
- interventionNames
- Biological: filgrastim
- Procedure: allogeneic bone marrow transplantation
Primary outcomes (1)
- measure
- Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following hematologic malignancies:
* Acute myeloid leukemia in first complete remission or second complete remission
* Chronic myeloid leukemia in chronic or accelerated phase
* Myelodysplasia, including any of the following:
* Refractory anemia (RA)
* RA with ringed sideroblasts
* RA with excess blasts (RAEB) I
* RAEB in transformation
* Chronic myelomonocytic leukemia
* Other hematologic malignancy for which sibling donor stem cell transplantation with a myeloablative conditioning regimen is appropriate, including any of the following:
* Indolent non-Hodgkin's lymphoma (NHL)
* Aggressive NHL
* Chronic lymphocytic leukemia
* Hodgkin's lymphoma
* Myelofibrosis
* Hematologic malignancy not otherwise specified
* HLA-matched sibling donor available meeting all of the following criteria:
* 6/6 HLA match
* HLA typing performed by serologic or DNA methodology for A and B and by DNA methodology for DRB1 (intermediate resolution)
* Not identical twin with patient
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No cognitive, linguistic, or emotional difficulty that would preclude participation in the quality-of-life component of the study
* Able to communicate in English or French
* No HIV antibody positivity
PRIOR CONCURRENT THERAPY:
* Not specifiedReferences
Publications (1)
- DERIVEDKariminia A, Ivison S, Ng B, Rozmus J, Sung S, Varshney A, Aljurf M, Lachance S, Walker I, Toze C, Lipton J, Lee SJ, Szer J, Doocey R, Lewis I, Smith C, Chaudhri N, Levings MK, Broady R, Devins G, Szwajcer D, Foley R, Mostafavi S, Pavletic S, Wall DA, Couban S, Panzarella T, Schultz KR. CD56bright natural killer regulatory cells in filgrastim primed donor blood or marrow products regulate chronic graft-versus-host disease: the Canadian Blood and Marrow Transplant Group randomized 0601 study results. Haematologica. 2017 Nov;102(11):1936-1946. doi: 10.3324/haematol.2017.170928. Epub 2017 Sep 21. PMID 28935847