Clinical trial · Interventional

Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers

Reduced-intensity, Related-donor Allogeneic BMT With Fludarabine, Busulfan, and High-dose Posttransplantation Cyclophosphamide for Hematologic Malignancies

NCT01135329CI-TRIAL-00112628terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): The stopping rule was met and hence the study was closed

Summary

Brief summary (as posted)

This research is being done to learn more about reduced-intensity bone marrow transplantation (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow from a relative. The main goal of the study is to determine how quickly the donor's bone marrow "takes" in your body. Other goals include describing how many people accept the bone marrow and how quickly the blood counts come up; describing Graft-versus-host disease (GVHD) and other complications; and describing how many people survive without progressive cancer and survive overall

Conditions

Conditions (3)

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 Syndrome	Myelodysplastic Syndrome	CURATED_BROADER	0.80

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Busulfan	Drug	Busulfan	ALIAS
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Fludarabine	Drug	Fludarabine	ALIAS
Mycophenolate Mofetil	Drug	—	UNRESOLVED
Tacrolimus	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
BMT Allogenic Transplantation
description
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
interventionNames
1. Drug: Fludarabine
2. Drug: Busulfan
3. Drug: Cyclophosphamide
4. Drug: Mycophenolate Mofetil
5. Drug: Tacrolimus

Primary outcomes (2)

measure
Chimerism in Unsorted Peripheral Blood
timeFrame
Day 60
description
Percentage of participants achieving full-donor chimerism in unsorted peripheral blood.
measure
Chimerism in CD3+ Sorted Peripheral Blood
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 6 Months
Maximum age: 75 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Aug 1, 2010
Primary completion: May 1, 2012
Completion: May 1, 2012
First posted: Jun 2, 2010
Last update posted: May 27, 2026
Results first posted: Jul 3, 2018
Enrollment: 15 (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins OTHER
Keywords: Lymphoma, Hodgkin's lymphoma, Non hodgkin's lymphoma, Leukemia, Acute myeloid leukemia (AML), Acute lymphoblastic leukemia(ALL), Chronic myeloid leukemia (CML), Chronic Myelomonocytic (CMML), Myelodysplastic syndrome (MDS), High-risk acute leukemia in first remission, Relapsed leukemia in remission, Cyclophosphamide, High-dose cyclophosphamide, Fludarabine, Busulfan, Allogeneic, Nonmyeloablative, Reduced intensity, Haploidentical, Bone marrow transplant (BMT)

Data updated 22 days agoSource updated May 27, 2026source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1