Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults

NCT00001637 | Completed Phase 2

• 2 other identifiers: 97020297-H-0202
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Diseases such as leukemia, lymphoma, and multiple myeloma fall into the category of blood cancers. Some of these conditions can now be cured by bone marrow transplantation (BMT). The ability of BMT to cure these conditions has been credited to the use of high doses of chemotherapy, radiation therapy, and the antileukemia effect of the transplant. Because the effectiveness of BMT relies on the use of high doses of chemotherapy and total body irradiation (TBI), it is a therapy associated with toxic side effects. These side effects are often deadly and have limited BMT for use in patients under the age of 55. In this study researchers plan to treat older patients between the ages of 55 to 75 years with blood cell transplants taken from donors who are genetically matched relatives of the patient. In order to decrease the toxic side effects associated with the transplant, researchers will not use chemoradiotherapy. Instead they plan to use intensive immunosuppressive therapy and allow the transplanted cells to take effect.

Conditions

Chronic Lymphocytic Leukemia; Graft vs Host Disease; Leukemia; Myelodysplastic Syndrome; Myeloid Leukemia

Keywords

Peripheral Blood Stem Cells; Engraftment; Fludarabine; Nonmyeloablative; Graft-Versus-Leukemia; Graft vs. Host Disease; Cyclophosphamide; Donor Apheresis; Nonmyeloablative Bone Marrow Transplantation; Chronic Myelogenous Leukemia (CML); Acute Lymphoblastic Leukemia (ALL); Acute Myelogenous Leukemia (AML); Myelodysplastic Syndromes; Chronic Lymphocytic Leukemia (CLL); Prolymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with clinically significant acute GHVD (Grade II or higher) following the T depleted PBPC transplant.

Interventions

Blood cell transplantation PROCEDURE

Eligibility Criteria

• Age: 55 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 55-71 years.
• Chronic myelogenous leukemia (CML): chronic phase.
• Acute lymphoblastic leukemia (ALL), all patients in complete or partial remission.
• Acute myelogenous leukemia (AML): AML in first complete or partial remission. Exceptions: AML with good risk karyotypes: AML M3 t(5;17), AML M4Eo (inv. 16), AML t(8;21). All AML in second or subsequent complete remission.
• Myelodyplastic syndromes: refractory anemia with excess of blasts (less than 10%) or early transformation to acute leukemia or Chronic myelomonocytic leukemia.
• Chronic lymphocytic leukemia (CLL) with bulky or progressive disease despite prior treatment with chemotherapy which includes purine analogs.
• Mantle cell lymphoma.
• Relapsed or progressive non-Hodgkins lymphoma, failing standard treatment approaches and unsuitable for autologous stem cell transplantation.
• No major organ dysfunction precluding transplantation.
• DLCO greater than or equal to 40% predicted.
• Left ventricular ejection fraction: greater than 30% predicted.
• ECOG performance status of 0-2.
• HLA identical family donor, up to 75 years old.
• Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke, no history of severe heart disease).
• Informed consent given.

You may not qualify if:

• Patient or donor pregnant or lactating.
• Patient age less than 55, greater than 71 years.
• ECOG performance status of 3 or more. Psychiatric disorder or mental deficiency of the patient or the donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
• Major anticipated illness or organ failure incompatible with survival from BMT.
• DLCO less than 40% predicted.
• Left ventricular ejection fraction less than 30% predicted.
• Serum creatinine greater than 2.5 mg/dl.
• Serum bilirubin greater than 4 mg/dl, transaminases greater than 5 times the upper limit of normal.
• HIV positive (donor or recipient). Donors who are positive for HBV, HCV, or HTLV will be used at the discretion of the investigator.
• Other malignant diseases liable to relapse or progress within 5 years.
• Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of heart failure or unstable angina, platelet count less than 90,000/cu mm).

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Rowe JM, Andersen JW, Mazza JJ, Bennett JM, Paietta E, Hayes FA, Oette D, Cassileth PA, Stadtmauer EA, Wiernik PH. A randomized placebo-controlled phase III study of granulocyte-macrophage colony-stimulating factor in adult patients (> 55 to 70 years of age) with acute myelogenous leukemia: a study of the Eastern Cooperative Oncology Group (E1490). Blood. 1995 Jul 15;86(2):457-62.

  PMID: 7605984 BACKGROUND

• Giralt S, Estey E, Albitar M, van Besien K, Rondon G, Anderlini P, O'Brien S, Khouri I, Gajewski J, Mehra R, Claxton D, Andersson B, Beran M, Przepiorka D, Koller C, Kornblau S, Korbling M, Keating M, Kantarjian H, Champlin R. Engraftment of allogeneic hematopoietic progenitor cells with purine analog-containing chemotherapy: harnessing graft-versus-leukemia without myeloablative therapy. Blood. 1997 Jun 15;89(12):4531-6.

  PMID: 9192777 BACKGROUND

• Schmitz N, Dreger P, Suttorp M, Rohwedder EB, Haferlach T, Loffler H, Hunter A, Russell NH. Primary transplantation of allogeneic peripheral blood progenitor cells mobilized by filgrastim (granulocyte colony-stimulating factor). Blood. 1995 Mar 15;85(6):1666-72.

  PMID: 7534141 BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Graft vs Host Disease; Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Prolymphocytic

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Marrow Diseases; Myeloproliferative Disorders

Study Officials

• A. John Barrett, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: September 29, 1997
• Primary Completion: July 28, 2008
• Study Completion: December 28, 2016
• Last Updated: December 17, 2019

Record last verified: 2016-12-28

Locations

US (1)