Clinical trial · Interventional
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer
Reduced Intensity Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): terminated early due to meeting end point with fewer patients than anticipated
Summary
Brief summary (as posted)
RATIONALE: Giving low doses of chemotherapy before a donor 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. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer 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 a monoclonal antibody, such as alemtuzumab, before transplant and tacrolimus and methotrexate after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of donor stem cell transplant and to see how well it works in treating patients with high-risk hematologic cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| graft-versus-tumor induction therapy | Biological | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Hematopoietic Stem Cell Transplantation
- description
- All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on donor type
- interventionNames
- Biological: alemtuzumab
- Biological: graft-versus-tumor induction therapy
- Biological: rituximab
- Drug: busulfan
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
- Drug: methotrexate
- Drug: tacrolimus
- Procedure: allogeneic bone marrow transplantation
Primary outcomes (1)
- measure
- Survival at Day 100
- timeFrame
- 100 day
- description
- Survival at Day 100
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 72 Years
Show eligibility criteria text
* Diagnosis of one of the following hematological malignancies:
* CML, with 1 of the following:
* In first CP AND failed imatinib mesylate therapy, defined as failure to obtain a hematologic remission at 3 months or a major cytogenetic response (i.e., Ph+ cells \< 35%) at 6 months or demonstrated clonal evolution or disease progression during therapy
* In accelerated phase with \< 15% blasts
* In blast crisis that has entered into a second CP following induction chemotherapy
* AML, with 1 of the following:
* In second or subsequent complete remission (CR) (i.e., \< 5% blasts by morphology, no residual leukemia by flow cytometry, and absence of cytogenetic abnormalities)
* Failed primary induction chemotherapy, but subsequently entered into a CR with ≤ 2 subsequent re-induction chemotherapy treatment(s)
* In first CR with intermediate-risk or poor-risk cytogenetics
* ALL with 1 of the following:
* In second or subsequent CR
* In first CR AND presence of t(9;22)
* MDS, with the following:
* High-risk disease, defined by IPSS score of ≥ 1.5 at diagnosis AND meets 1 of the following criteria:
* ≤ 10% blasts at diagnosis
* In morphologic CR (\< 5% blasts) following cytoreductive chemotherapy
* CMML, with 1 of the following:
* ≤ 10% blasts at diagnosis
* In morphologic CR (\< 5% blasts) following cytoreductive chemotherapy
* CLL/PLL with the following:
* Rai stage I-IV disease
* Failed ≥ 1 prior chemotherapy regimen (including fludarabine phosphate) or ASCT
* Documented chemosensitive or stable, non-bulky disease prior to transplant, defined as \< 20% bone marrow involvement AND lymph node size \< 3 cm in axial diameter
* No bulky tumor masses, elevated lactate dehydrogenase (LDH), B symptoms, or progressive disease prior to transplant
* Low-grade non-Hodgkin lymphoma (NHL) (i.e., small lymphocytic lymphoma, follicular center lymphoma \[grade 1 or 2\], marginal zone lymphoma, or B-cell lymphoma), with the following criteria:
* Failed ≥ 1 prior chemotherapy regimen or ASCT
* Documented chemosensitive or stable, non-bulky disease prior to transplant, defined as \< 20% bone marrow involvement AND lymph node size \< 3 cm in axial diameter
* Received ≤ 3 prior chemotherapy regimens (monoclonal antibody therapy and involved-field radiotherapy are not considered a prior regimen)
* No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant
* Mantle cell lymphoma, with the following:
* Failed to achieve remission or recurred after either conventional chemotherapy or ASCT
* Responsive or stable disease to most recent prior therapy
* No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant
* Intermediate-grade NHL (i.e., follicular center lymphoma \[grade 3\] or diffuse large cell lymphoma), meeting the following criteria:
* Failed to achieve remission or recurred after either conventional chemotherapy or ASCT
* Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites)
* No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant
* Hodgkin lymphoma, with the following:
* Relapsed after prior ASCT OR after ≥ 2 combination chemotherapy regimens and ineligible for ASCT
* Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites)
* No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant
* Peripheral T-cell NHL, with the following:
* Failed to achieve remission or recurred after either conventional chemotherapy or ASCT
* Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites)
* No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant
* Myeloproliferative syndrome with poor risk features, meeting 1 of the following criteria:
* \< 55 years old AND Lille score of 1
* Lille score of 2
* HgB \< 10 g/dL AND abnormal karyotype
* High-risk disease, with 1 of the following:
* Age 40-72 years
* Any age AND deemed to be at significantly increased risk of morbidity and death following a standard, myeloablative unrelated donor stem cell transplant (e.g., received extensive prior therapy, including ASCT)
* HLA-matched unrelated donor available, with 1 of the following:
* 8/8 match at HLA-A, B, C, or DR loci by high-resolution genotyping
* Single allelic mismatch at either the HLA-B or HLA-C loci donor by high-resolution molecular typing
* No single allelic mismatch at HLA-A or HLA-DR loci
* KPS 80-100%
* Adapted weighted Charlson Comorbidity Index \< 3
* Serum creatinine ≤ 2.0 mg/dL
* AST or ALT \< 3 times upper limit of normal (ULN)
* Total bilirubin \< 1.5 times ULN
* LVEF ≥ 45%
* DLCO \> 50%
* No hypoxia at rest with oxygen saturation \< 92% on room air (corrected with bronchodilator therapy)
* No other severe pulmonary function abnormalities
* No HIV infection
* No active hepatitis B or C infection that, in the opinion of a gastroenterologist or the transplant committee, places the patient at moderate to high risk for developing severe hepatic disease
* No active opportunistic infection (e.g., fungal pneumonia, tuberculosis, or viral infection)References
Publications (23)
- BACKGROUNDMcGlave PB, Shu XO, Wen W, Anasetti C, Nademanee A, Champlin R, Antin JH, Kernan NA, King R, Weisdorf DJ. Unrelated donor marrow transplantation for chronic myelogenous leukemia: 9 years' experience of the national marrow donor program. Blood. 2000 Apr 1;95(7):2219-25. PMID 10733488
- BACKGROUNDSierra J, Storer B, Hansen JA, Martin PJ, Petersdorf EW, Woolfrey A, Matthews D, Sanders JE, Storb R, Appelbaum FR, Anasetti C. Unrelated donor marrow transplantation for acute myeloid leukemia: an update of the Seattle experience. Bone Marrow Transplant. 2000 Aug;26(4):397-404. doi: 10.1038/sj.bmt.1702519. PMID 10982286
- BACKGROUNDWeisdorf DJ, Billett AL, Hannan P, Ritz J, Sallan SE, Steinbuch M, Ramsay NK. Autologous versus unrelated donor allogeneic marrow transplantation for acute lymphoblastic leukemia. Blood. 1997 Oct 15;90(8):2962-8. PMID 9376576
- BACKGROUNDAnderson JE, Anasetti C, Appelbaum FR, Schoch G, Gooley TA, Hansen JA, Buckner CD, Sanders JE, Sullivan KM, Storb R. Unrelated donor marrow transplantation for myelodysplasia (MDS) and MDS-related acute myeloid leukaemia. Br J Haematol. 1996 Apr;93(1):59-67. doi: 10.1046/j.1365-2141.1996.4811022.x. PMID 8611476
- BACKGROUNDIzutsu K, Kanda Y, Ohno H, Sao H, Ogawa H, Miyazaki Y, Kawa K, Kodera Y, Kato S, Morishima Y, Hirai H; Japan Marrow Donor Program. Unrelated bone marrow transplantation for non-Hodgkin lymphoma: a study from the Japan Marrow Donor Program. Blood. 2004 Mar 1;103(5):1955-60. doi: 10.1182/blood-2003-03-0937. Epub 2003 Nov 6. PMID 14604976
- BACKGROUNDShaw BE, Peggs K, Bird JM, Cavenagh J, Hunter A, Alejandro Madrigal J, Russell NH, Sirohi B, Towlson K, Williams CD, Marks DI; Clinical Trials Committee of the British Society of Blood and Marrow Transplantation. The outcome of unrelated donor stem cell transplantation for patients with multiple myeloma. Br J Haematol. 2003 Dec;123(5):886-95. doi: 10.1046/j.1365-2141.2003.04714.x.