Reduced Intensity Double Umbilical Cord Blood Transplantation

NCT ID: NCT01408563

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2017-06-30

Brief Summary

This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells.

Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.

Detailed Description

Subjects will receive their transplants as in-patients.

• IV-Catheter

• one or two IV catheters will be placed on the day of hospital admission
• Conditioning

• Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)
• Melphalan IV (day -1)
• Total body radiation on day 0 (same day as transplant)
• Immunosuppressive Therapy

• Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant. Given IV as in-patient, orally as out-patient
• Infusion of Cord Blood units

• 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be provided

Conditions

Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia; Acute Myelogenous Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fludarabine/Melphalan/TBI

All patients receive same therapy

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

30 mg/m2/day IV x 6 days

Melphalan

Intervention Type: DRUG

100 mg/m2/day IV x 1 day

Total Body Radiation

Intervention Type: RADIATION

200 cGy on Day 0

Cord Blood

Intervention Type: BIOLOGICAL

2 cord blood units IV

Interventions

Fludarabine

30 mg/m2/day IV x 6 days

Intervention Type: DRUG

Melphalan

100 mg/m2/day IV x 1 day

Intervention Type: DRUG

Total Body Radiation

200 cGy on Day 0

Intervention Type: RADIATION

Cord Blood

2 cord blood units IV

Intervention Type: BIOLOGICAL

Other Intervention Names

Fludara

Eligibility Criteria

Inclusion Criteria

• Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate
• Appropriate candidate for reduced intensity regimen, according to the treating physician
• Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant
• Able to comply with the requirements for care after allogeneic stem cell transplantation

Exclusion Criteria

• Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction
• Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease
• Renal disease
• Hepatic disease
• Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
• HIV-positive
• Uncontrolled infection
• Pregnant or breast-feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zachariah Michael DeFilipp

Hematology/Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zachariah DeFilipp, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

11-085

Identifier Type: -

Identifier Source: org_study_id