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Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma

NCT ID: NCT00506129

Last Updated: 2020-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2015-06-30

Brief Summary

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The goal of this clinical research study is to see if receiving a transplant of blood stem cells (cells that can produce blood) or bone marrow from either a related donor (brother, sister or other relative) or an unrelated voluntary donor will help patients with advanced cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain free of disease will also be studied.

Detailed Description

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You will receive the chemotherapy drug fludarabine for 5 days (Days 1 to 5). The drug melphalan will be given on Days 4 and 5. You may also receive the drug anti-thymocyte globulin (ATG) on Days 4, 5, 6. This will be followed by infusion of blood stem cells or bone marrow from a donor on Day 7. A separate consent will be provided to the donor. The donor can be a brother, sister or another family member or a compatible unrelated donor. The drugs and the stem cells will be given through a catheter (a small tube) placed under the collarbone. You may receive your treatment on an inpatient or outpatient basis. If treated on an inpatient basis, you will stay in the hospital during treatment and recovery, which can take 4 to 5 weeks even if there are no complications.

The chemotherapy and the ATG are given to help the body accept the transplanted stem cells or bone marrow. You will receive antibiotics to fight infection and a medicine called G-CSF (Neupogen®) to help blood counts rise back to healthier levels. G-CSF is given as an injection under the skin. You will also need blood and platelet transfusions.

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

If the cancer grows and graft-versus-host disease is not present, you may be eligible to receive donor blood cells (lymphocytes) infused through the catheter. This may cause graft-versus-host disease and may help shrink the cancer. If the cancer grows and graft-versus-host disease is already present, then donor lymphocytes are not given.

Sometimes, the body rejects the donor cells; this reaction is called "graft rejection". Sometimes the donor cells attack the body, a reaction called graft-versus-host disease (GvHD). The drugs tacrolimus and methotrexate will be given to help prevent these reactions from occurring. These drugs are given through a vein or by mouth before and/or after the transplant.

You must stay in the Houston area for at least 100 days after the transplant. After 100 days, you must return to Houston every 3 months for 2 years for tests and checkups, then once a year for at least 3 years. If there is no sign of lymphoma growth at the follow up visit(s), you will receive no further treatment.

This is an investigational study. The drugs used in this study are approved by the FDA and are commercially available. As many as 35 patients will take part in the study. All will be enrolled at MD Anderson.

Conditions

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Lymphoma Disorder Related to Bone Marrow Transplantation

Keywords

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Cutaneous T-Cell Lymphoma CTCL Allogeneic Transplantation Lymphoma Allogeneic peripheral blood progenitor cell PBPC Bone Marrow transplantation Stem Cell Transplant SCT Fludarabine Fludarabine Phosphate Fludara Melphalan

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fludarabine + Melphalan with PBPC

Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m\^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.

Group Type EXPERIMENTAL

Fludarabine

Intervention Type DRUG

25 mg/m\^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant.

Melphalan

Intervention Type DRUG

70 mg/m\^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant.

Allogeneic Transplant

Intervention Type PROCEDURE

Allogeneic transplant given by vein after completion of Fludarabine and Melphalan.

Thymoglobulin

Intervention Type DRUG

2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.

Interventions

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Fludarabine

25 mg/m\^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant.

Intervention Type DRUG

Melphalan

70 mg/m\^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant.

Intervention Type DRUG

Allogeneic Transplant

Allogeneic transplant given by vein after completion of Fludarabine and Melphalan.

Intervention Type PROCEDURE

Thymoglobulin

2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.

Intervention Type DRUG

Other Intervention Names

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Fludarabine Phosphate Fludara Allogeneic peripheral blood progenitor cell PBPC Bone Marrow transplantation Stem Cell Transplant SCT ATG Antithymocyte Globulin

Eligibility Criteria

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Inclusion Criteria

1. Patients with pathologically proven cutaneous T-cell lymphoma (CTCL), disease stage IIB to IVB, patients must be in at least a partial response-PR (skin and lymph nodes) after receiving other non-allogeneic transplant therapy, age \</= 70 years, Zubrod performance status 0 or 1, left ventricular ejection fraction \>/= 50% or approved for transplant by a cardiologist, DLCO \>/= 50% predicted or approved for transplant by a pulmonologist, serum creatinine \</= 1.5 mg/dL, serum bilirubin \< 2mg/dL. SGPT \< 3 x upper limit of normal, and no previous history of allogeneic transplantation.
2. Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).

Exclusion Criteria

1\) Patients cannot have active central nervous system (CNS) disease.
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chitra M. Hosing, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Hosing C, Bassett R, Dabaja B, Talpur R, Alousi A, Ciurea S, Popat U, Qazilbash M, Shpall EJ, Oki Y, Nieto Y, Pinnix C, Fanale M, Maadani F, Donato M, Champlin R, Duvic M. Allogeneic stem-cell transplantation in patients with cutaneous lymphoma: updated results from a single institution. Ann Oncol. 2015 Dec;26(12):2490-5. doi: 10.1093/annonc/mdv473. Epub 2015 Sep 28.

Reference Type DERIVED
PMID: 26416896 (View on PubMed)

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2012-01547

Identifier Type: REGISTRY

Identifier Source: secondary_id

DM03-0279

Identifier Type: -

Identifier Source: org_study_id