Trials / Completed

CompletedNCT01181271

Tandem Auto-Allo Transplant for Lymphoma

Sequential Myeloablative Autologous Stem Cell Transplantation Followed by Allogeneic Non-Myeloablative Stem Cell Transplantation for Patients With Poor Risk Lymphomas

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 42 (actual)

Sponsor: Massachusetts General Hospital · Academic / Other
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

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.

Detailed description

This is a phase II clinical trial investigating the feasibility, and efficacy of sequential autologous stem cell transplant followed by non-myeloablative allogeneic transplant for patients with poor risk lymphoma. Patients will be enrolled onto the trial when eligible and undergo standard high-dose chemotherapy with the combination with busulfan, cyclophosphamide, and etoposide followed by autologous stem cell transplant. After recovery of counts and clinical status, patients will then proceed to non-myeloablative allogeneic stem cell transplant using a fully matched related or unrelated donor.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2010-08-01
Primary completion: 2014-02-01
Completion: 2016-02-01
First posted: 2010-08-13
Last updated: 2017-03-09
Results posted: 2017-03-09

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01181271. Inclusion in this directory is not an endorsement.