Clinical trial · Interventional
Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
A Prospective Trial to Evaluate the Role of In Vivo T Cell Depletion by Campath® (Alemtuzumab) in Reduction of Transplant Related Mortality in Transplantation From HLA-Class I or Class II Mismatched, Unrelated Donors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. When the healthy stem 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how well it works in treating patients with 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 |
|---|---|---|---|
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alemtuzumab
- description
- Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
- interventionNames
- Biological: alemtuzumab
- Drug: busulfan
- Drug: cyclophosphamide
- Drug: methotrexate
- Drug: tacrolimus
- Procedure: allogeneic hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality
- timeFrame
- Up to day 180
- description
- Lowest dose of alemtuzumab associated with transplant-related mortality at day 180
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Confirmed diagnosis of one of the following:
* Primary acute myeloid leukemia (AML) meeting any of the following criteria:
* First complete remission (CR; defined as \< 5% blasts in marrow) with high-risk features as defined by failure to achieve remission by day 21 after induction chemotherapy, or the presence of chromosomal abnormalities involving any of the following:
* -5/del(5q)
* -7/del(7q)
* Inversion 3q
* Abnormalities of 11q23, 20q, 21q, del(9q),
* Translocation 6;9
* Translocation 9;22
* Abnormalities of 17p
* Complex karyotype with ≥ 3 abnormalities
* Second CR or subsequent in remission
* Refractory or relapsed disease
* Secondary AML in remission or relapse
* Chronic myelogenous leukemia (CML) in accelerated or blast phase meeting the following criteria:
* Accelerated phase is defined by any one of the following:
* Blasts 10% to 19% of peripheral blood white cells or bone marrow cells
* Peripheral blood basophils ≥ 20%
* Persistent thrombocytopenia (\< 100,000/mm³) unrelated to therapy, or persistent thrombocytosis (\> 1,000,000/mm³) unresponsive to therapy
* Increasing spleen size and increasing WBC count unresponsive to therapy
* Cytogenetic evidence of clonal evolution (i.e., the appearance of an additional genetic abnormality that was not present in the initial specimen at the time of diagnosis of chronic phase CML)
* Blast phase is defined by any of the following:
* Blasts ≥ 20% of peripheral blood white cells or bone marrow cells
* Extramedullary blast proliferation
* Large foci or clusters of blasts in bone marrow biopsy
* Primary myelodysplastic syndromes (MDS) with an IPSS score \> 1.5
* Secondary MDS with any IPSS score
* Primary acute lymphoblastic leukemia meeting any of the following criteria:
* First CR (\< 5% blasts in marrow) with high-risk features as defined by 1 of the following:
* Failure to achieve remission after first induction chemotherapy
* Presence of chromosomal abnormalities including hypodiploidy or abnormalities of 11q23 or translocation 9;22
* Second CR or subsequent in remission
* Refractory or relapsed disease
* No patients for whom a suitable HLA genotypically identical sibling or fully matched HLA-A, -B, -C, and -DRB1 unrelated donor is available
* No active CNS involvement with disease
* Donors must meet the following criteria:
* Unrelated volunteer donors who are mismatched for more than one HLA-class I alleles or antigens or for one HLA-class I antigen, but matched by high-resolution typing at HLA-DRB1 and -DQB1, OR who are mismatched for one or more HLA-class II alleles or antigens, but matched by high-resolution typing at HLA-A, -B, and -C
* No two-antigen mismatch at a single HLA-A, -B, or -C locus
* No mismatching of class I and class II HLA
* Matching must be based on results of high-resolution typing at HLA-A, -B, -C, - DRB1, and -DQB1
PATIENT CHARACTERISTICS:
* Karnofsky performance status 50-100%
* No symptomatic coronary artery disease or symptomatic congestive heart failure
* No hepatic disease with transaminases or bilirubin \> 2 times upper limit of normal except for isolated hyperbilirubinemia attributed to Gilbert's syndrome
* No severe hypoxemia with room air P\_AO\_2 \< 70, supplemental oxygen-dependence, or DLCO \< 60% predicted
* No impaired renal function with creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% normal
* Not HIV seropositive
* Not pregnant or breast-feeding
* Fertile patients must use effective contraception
* No active infections that are untreated or failing to respond to appropriate therapy
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* See Disease Characteristics
Exclusion criteria:
* Prior allogeneic or autologous bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation using a high-dose total-body irradiation regimenReferences
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