Mini transplant shows promise for blood cancers – but trial ended early
NCT ID NCT01135329
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a reduced-intensity bone marrow transplant, or 'mini transplant,' for people with blood cancers like lymphoma and leukemia. The transplant used marrow from a relative and was combined with chemotherapy drugs to help the donor cells take hold. Only 15 people took part before the trial was stopped early. The main goal was to see how well the donor cells engrafted, but the small size and early end mean we can't draw firm conclusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bone marrow transplant with chemotherapy drugs (fludarabine, busulfan, cyclophosphamide) and immune-suppressing drugs (mycophenolate mofetil, tacrolimus)
- What this could lead to
- If successful, this approach could offer a less intense transplant option for blood cancer patients, potentially reducing side effects while still controlling the disease.
- What could go wrong
- This was a small, early-phase trial that ended early, so results are limited. The transplant still carries risks like graft-versus-host disease and infection, and it may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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15 people
The number who actually took part.
- Start date
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Aug 2010
- Finished
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May 2012
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 months to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * First-degree related donor who is at minimum HLA haploidentical * Eligible diagnoses: 1. Low-grade non-Hodgkin's lymphoma or plasma cell neoplasm that has progressed during multiagent therapy, failed at least two prior therapies (excluding single agent rituximab and single agent steroids), or in the case of lymphoma undergone histological conversion: * Follicular grade 1 or 2 lymphoma * Follicular lymphoma not otherwise specified * Marginal zone (or MALT) lymphoma * Lymphoplasmacytic lymphoma / Waldenstrom's macroglobulinemia * Hairy cell leukemia * Small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) * Prolymphocytic leukemia * Low grade B-cell lymphoma, unspecified * Multiple myeloma * Plasma cell leukemia 2. Poor-risk SLL or CLL, defined by an 11q or 17p deletion, histological conversion, or disease progression \< 6 months after a purine analog-containing regimen 3. Aggressive lymphoma that has failed at least one prior regimen of multiagent chemotherapy, and patient is either ineligible for autologous BMT or autologous BMT is not recommended: * Hodgkin lymphoma * Follicular grade 3 lymphoma * Mantle cell lymphoma or leukemia * Diffuse large B-cell lymphoma (excluding primary CNS lymphoma). Eligible subtypes include primary mediastinal large B-cell lymphoma, T-cell rich large B-cell lymphoma, and large B-cell lymphoma not otherwise specified. * Burkitt's lymphoma/leukemia * Atypical Burkitt's lymphoma/leukemia (high grade B-cell lymphoma, unclassified, including that with features intermediate between Burkitt's and diffuse large B-cell lymphoma) * Anaplastic large cell lymphoma * Plasmablastic lymphoma * Peripheral T-cell lymphoma 4. Relapsed or refractory acute leukemia in second or subsequent remission 5. Poor-risk acute leukemia in first remission 6. AML with at least one of the following: * AML arising from MDS or a myeloproliferative disorder, or secondary AML * Presence of Flt3 internal tandem duplications * Poor-risk cytogenetics * Primary refractory disease * ALL (leukemia and/or lymphoma) with at least one of the following: * Adverse cytogenetics * Clear evidence of hypodiploidy * Primary refractory disease * Biphenotypic leukemia * MDS with at least one of the following features: * Poor-risk cytogenetics * IPSS score of INT-2 or greater * Treatment-related MDS * MDS diagnosed before age 21 years * Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy * Life-threatening cytopenias, including those generally requiring greater than weekly transfusions 7. Interferon- or imatinib-refractory CML in first chronic phase, or non-blast crisis CML beyond first chronic phase 8. Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis) 9. Chronic myelomonocytic leukemia 10. Juvenile myelomonocytic leukemia * For patients with SLL, CLL, or prolymphocytic leukemia, \< 20% of bone marrow cellularity involved by this process * Adequate end-organ function: * Left ventricular ejection fraction greater than or equal to 35% * Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \< 5 x ULN * FEV1 and FVC \> 40% of predicted; or in pediatric patients, if unable to perform pulmonary function tests due to young age, oxygen saturation \>92% on room air * ECOG performance status \< 2 or Karnofsky or Lansky score \> 60 Exclusion Criteria: * Pregnant or breast-feeding * Uncontrolled infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis. * Any previous BMT within 3 months prior to start of conditioning * Active extra-medullary leukemia or known active Central Nervous System (CNS) involvement by malignancy. Such disease treated into remission is permitted.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Sydney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
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