Safety Study of Bone Marrow Transplant Using Mismatched Tissue Followed by Chemotherapy

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if giving high dose chemotherapy and total body irradiation before and repeating high dose chemotherapy after a bone marrow transplant could reduce the incidence of graft rejection and disease for patients with blood cancers

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Center for Research Resources (NCRR); Otsuka Pharmaceutical Co., Ltd.
• Treatments: Busulfan; Cyclophosphamide

Criteria

Inclusion Criteria:

• Acute lymphocytic leukemia in high risk CR1

• Acute myeloid leukemia in CR1

• Therapy-related AML

• RAEB with >5% and <20% bone marrow blasts

• Chronic myelogenous leukemia beyond 1st chronic phase; Patients cannot be in blast crisis

• CMMoL

• JMML

• Chemotherapy-resistant Hodgkins Lymphoma or intermediate or high grade Non-Hodgkins lymphoma (Less than a PR after standard or salvage chemotherapy)

• Mantle cell lymphoma: chemotherapy refractory (Less than a PR after standard or salvage chemotherapy) or patients beyond CR1 with chemosensitive disease

• Follicular Lymphoma, Grade 3

• Transformed indolent lymphomas

Exclusion Criteria:

• Poor cardiac function: left ventricular ejection fraction <45% as determined by MUGA or ECHO. For pediatric patients LVEF <45% or a shortening fraction below normal limits for age.

• Poor pulmonary function: FEV1 and FVC <50% predicted for patients who have not received thoracic or mantle irradiation. For patients who have received thoracic or mantle irradiation, FEV1 and FVC <70% predicted or DLCO < 50 of predicted. For children unable to perform PFTs because of developmental stage pulse oximetry < 85% on RA

• Poor liver function: bilirubin >2 mg/dl (not due to hemolysis, Gilbert's or primary malignancy)

• Poor renal function: Creatinine >2.0mg/dl or creatinine clearance

• HIV-positive

• Positive leukocytotoxic crossmatch

• Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception

• Uncontrolled viral, bacterial, or fungal infections Patients with symptoms consistent with RSV, influenza A, B, or parainfluenza at the time of enrollment will be assayed for the above viruses and if positive are not eligible for the trial until they are no longer symptomatic (patients may have continued assay positivity for a period of time post resolution of symptoms secondary to the nature of the assay.

• Indolent lymphomas (Follicular Grade 1 and 2, marginal zone, chronic lymphocytic leukemia, small lymphocytic lymphoma, MALT)