Tandem Auto-Allo Transplant for Lymphoma

Summary

Relapse remains a principle cause of treatment failure for patients with aggressive lymphoma after autologous transplantation. Non-myeloablative allogeneic transplantation allows patients to receive an infusion of donor cells in an attempt to induce a graft versus lymphoma effect. This study will assess the feasibility, safety and efficacy of the combination of autologous stem cell transplantation followed by non-myeloablative transplantation for patients with poor-risk aggressive lymphoma.

Conditions

• Diffuse, Large B-Cell, Lymphoma
• Lymphoma, Low-Grade
• T-Cell Lymphoma
• Mantle-Cell Lymphoma
• Hodgkin's Lymphoma
• Chronic Lymphocytic Leukemia
• Lymphoma, Small Lymphocytic

Interventions

DRUG

Busulfan (conditioning for AUTO transplant)

0.8 mg/kg intravenous (IV) bolus every six hours (Q6H) on days -8,-7,-6,-5 (total of 14 doses). The total daily dose of busulfan will be 3.2 mg/kg on days -8,-7, and -6 and 1.6 mg/kg on day -5

DRUG

Etoposide (conditioning for AUTO transplant)

Etoposide 30 mg/kg IV bolus every day (QD) on day -4. The total daily dose of etoposide will be 30 mg/kg.

DRUG

Cyclophosphamide (conditioning for AUTO transplant)

Cyclophosphamide 60 mg/kg IV bolus QD on days -3 and -2. The total daily dose of cyclophosphamide will be 60 mg/kg.

DRUG

Mesna (prior to AUTO transplant)

Mesna 15 mg/kg IV bolus on days -3 and -2 infused over 15 minutes and given 15 minutes prior to cyclophosphamide administration. This is followed by Mesna given 15 mg/kg IV bolus three times daily (TID) on days -3 and -2 infused over 15 minutes at 3, 6, and 9 hours after completion of cyclophosphamide infusion. Total daily dose of Mesna should be equivalent to daily dose of cyclophosphamide. Lastly, Mesna will be given at 15 mg/kg IV bolus QD on day -1. This makes a total of 9 doses of Mesna

OTHER

autologous (auto) peripheral blood stem cell transplantation

Infusion of autologous peripheral blood stem cells on Day 0.

DRUG

Neupogen

Neupogen 5 mcg/kg subcutaneous (SQ) daily starting on day +1 until absolute neutrophil count (ANC) is greater than or equal to 1000 per micro liter on two separate occasions or greater than 5000 per micro liter once

DRUG

Fludarabine (conditioning for ALLO Transplant)

Fludarabine 30 mg/m2/day will be administered as a bolus infusion over approximately 30 minutes for 4 days on days -5, -4, -3, -2.

DRUG

Busulfan (conditioning for ALLO Transplant)

Busulfan will be administered by IV infusion over approximately 3 hours on days -5, -4, -3, -2. The dose of busulfan will be 0.8 mg/kg/day

OTHER

non-myeloablative allogeneic (allo) transplant

Donor peripheral blood stem cells (PBSC) will be infused intravenously beginning on Day 0. The minimum total CD34+ cell dose will be 2 x 10\^6 CD34+cells/kg of recipient's actual body weight with a maximum dose of 8 x 10\^6/kg of recipient's actual body weight

DRUG

Tacrolimus

Tacrolimus (FK506) will be given orally at a dose of 0.05 mg/kg orally (PO) twice a day (BID) starting day -3.

DRUG

Sirolimus

Sirolimus (rapamycin) will be given orally at a dose of 12 mg times one on day -3 and then the dose shall be 4 mg by mouth daily starting on day -2. The dose may then be adjusted according to serum levels at the discretion of the treating physician

DRUG

Methotrexate

Methotrexate will be administered once daily on days 1, 3, and 6 as an IV bolus over 15 minutes at a dose of 5 mg/m2

Sponsors & Collaborators

• Dana-Farber Cancer Institute

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Yi-Bin A Chen, MD · Massachusetts General Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2014-02-28

Completion

2016-02-29

Countries

• United States

Study Locations