Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma

Summary

Background:

Lymphoma is a type of blood cancer. Blood cell transplant can cure some people with lymphoma. Researchers want to see if they can limit the complications transplant can cause.

Objective:

To test if a stem cell transplant can cure or control lymphoma. Also to test if new ways of getting a recipient ready for a transplant may result in fewer problems and side effects.

Eligibility:

Recipients: People ages 12 and older with peripheral T cell lymphoma that does not respond to standard treatments

Donors: Healthy people ages 18 and older whose relative has lymphoma

Design:

Participants will be screened with:

Physical exam

Blood and urine tests

Bone marrow biopsy: A needle inserted into the participant s hip bone will remove marrow.

Donors will also be screened with:

X-rays

Recipients will also be screened with:

Lying in scanners that take pictures of the body

Tumor sample

Donors may donate blood. They will take daily shots for 5 7 days. They will have apheresis: A machine will take blood from one arm and take out their stem cells. The blood will be returned into the other arm.

Recipients will be hospitalized at least 2 weeks before transplant. They will get a catheter: A plastic tube will be inserted into a vein in the neck or upper chest. They will get antibody therapy or chemotherapy.

Recipients will get the transplant through their catheter.

Recipients will stay in the hospital several weeks after transplant. They will get blood transfusions. They will take drugs including chemotherapy for about 2 months.

Recipients will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.

...

Conditions

• Peripheral T-cell Lymphomas
• Lymphoproliferative Disorders
• Immune System Diseases

Interventions

DRUG

ATL-RIC

e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m2/day IV on days -11 and -7, low-dose cyclophosphamide (5 mg/kg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, filgrastim or biosimilar drug 5mcg /kg/day subcutaneous on days -12, -8, and -4, ruxolitinib 45 mg/day from day -12 through day -2, and zidovudine 300mg orally three times a day from day -1 through day +50.

DRUG

mRIC

e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m2/day IV on days -11 and -7, lowdose cyclophosphamide (5 mg/kg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, filgrastim or biosimilar drug 5 mcg/kg/day subcutaneous on days -12, -8, and -4.

PROCEDURE

allo HCT

Stem cell transplant

DRUG

RIC

e-ATG 40 mg/kg/day IV on days -14 and -13. Pentostatin 4mg /m2/day IV on days -11 and -7. Cyclophosphamide 5 mg/kg orally daily on days -11 through -4. Busulfan IV, pharmacokinetically dosed, on days -3 and -2.

DRUG

GVHD prophylaxis

High-dose, post-transplantation cyclophosphamide (PTCy) on days +3 and +4 ( 25 mg/kg/day on both arms), sirolimus on days +5 through +60, and mycophenolate mofetil (MMF) on days +5 through +25.

DRUG

IOC

e-ATG40 mg/kg/day IV on days -14 and -13. Pentostatin 4 mg/m2/day IV on days -9 and -5. Cyclophosphamide 5 mg/kg orally daily on days -9 through -2

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Dimana Dimitrova, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-04-18

Primary Completion

2026-10-31

Completion

2030-10-31

FDA Drug

Yes

Countries

• United States

Study Locations