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Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide

NCT00809276•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

Detailed Description

A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT) However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT

Eligibility

Age

0 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients ages between 0 to and 65 years of age.
•Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
•Acute lymphocytic leukemia (ALL) in CR1 with high risk features
•Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
•i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype \[\> 3 abnormalities\]
•Acute Leukemias in 2nd or greater remission
•Refractory or Relapsed AML
•AML transformed from MDS
•Myelodysplastic syndrome (MDS) beyond refractory anemia
•Chronic myeloid leukemia (CML)
+4 more criteria

Exclusion Criteria

•Prior autologous or allogeneic stem cell transplant.
•Performance status greater than 2
•Active infection.
•Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
•Inadequate pulmonary function; FEV1, FVC, DLCO \<50% of predicted
•Inadequate Serum creatinine clearance \<60
•InadequatebHepatic function
•Positive serology for HIV-1, 2 or HTLV-1, 2.
•Pregnancy. Female patient must have negative pregnancy test

Locations (3)

The Sydney Kimmel Comprehensive Cancer center

Baltimore, Maryland, United States

Marcos deLima, MD

Houston, Texas, United States

Paul V. O'Donnell, M.D., Ph.D.

Seattle, Washington, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

December 1, 2011

Completion Date

December 1, 2011

Last Updated

February 16, 2015

Enrollment

ACTUAL participants

Conditions

LymphomaMultiple MyelomaLeukemiaMyelodysplastic Syndrome

Interventions

Busulfan, Fludarabine, Cytoxan

DRUG

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

NCT06311227

Recurrent Hairy Cell LeukemiaRecurrent Hairy Cell Leukemia Variant

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RECRUITINGPHASE1

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

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RECRUITINGPHASE2

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 16, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

Inclusion Criteria

Exclusion Criteria

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

Phase I Study of HC-7366 for Acute Myeloid Leukemia

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

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