Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Donor Stem Cell Transplant in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia - Full Text View

Sponsor:	III. Medizinische Klinik Mannheim
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055874

Purpose

RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, imatinib mesylate may stop the growth of cancer cells by blocking the enzymes needed for cancer cell growth. Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known which treatment regimen is most effective in treating chronic phase chronic myelogenous leukemia.

PURPOSE: This randomized phase III trial is studying imatinib mesylate with or without interferon alfa or cytarabine to see how well it works compared with interferon alfa followed by donor stem cell transplant in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia.

Condition	Intervention	Phase
Leukemia	Biological: recombinant interferon alfa Drug: cytarabine Drug: hydroxyurea Drug: imatinib mesylate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Treatment Optimization Trial in Chronic Myeloid Leukemia (CML) - Randomized Controlled Comparison of Imatinib vs. Imatinib/Interferon-alpha vs. Imatinib/Low-Dose AraC vs. Interferon-alpha Standard Therapy and Determination of the Role of Allografting in Newly Diagnosed Chronic Phase

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Chronic Myeloid Leukemia Leukemia

Drug Information available for: Cytarabine hydrochloride Interferon alfa-2a Imatinib Imatinib mesylate Interferon alfa-n1 Hydroxyurea Cytarabine Interferons

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Risk group-dependent survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Hematologic, cytogenetic, and molecular response rates [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse drug effects [ Designated as safety issue: Yes ]
Quality of life [ Designated as safety issue: No ]

Estimated Enrollment:	1600
Study Start Date:	June 2002
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed chronic phase chronic myelogenous leukemia (CML)
- bcr-abl positive
- No blasts, promyelocytes, myelocytes, or metamyelocytes in the peripheral blood
Availability of a HLA-identical sibling or unrelated donor

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No second malignancy requiring therapy
No evidence of disease-related symptoms or extramedullary disease (including hepatosplenomegaly)
No serious diseases that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior interferon

Chemotherapy

No prior chemotherapy other than hydroxyurea

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

Not specified

Other

Prior anagrelide allowed
No participation in another clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055874

Show 66 Study Locations

Sponsors and Collaborators

III. Medizinische Klinik Mannheim

Investigators

Study Chair:

Ruediger Hehlmann, MD

III. Medizinische Klinik Mannheim

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Hehlmann R, Lauseker M, Jung-Munkwitz S, Leitner A, Müller MC, Pletsch N, Proetel U, Haferlach C, Schlegelberger B, Balleisen L, Hänel M, Pfirrmann M, Krause SW, Nerl C, Pralle H, Gratwohl A, Hossfeld DK, Hasford J, Hochhaus A, Saussele S. Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-? in newly diagnosed chronic myeloid leukemia. J Clin Oncol. 2011 Apr 20;29(12):1634-42. Epub 2011 Mar 21.

Burchert A, Müller MC, Kostrewa P, Erben P, Bostel T, Liebler S, Hehlmann R, Neubauer A, Hochhaus A. Sustained molecular response with interferon alfa maintenance after induction therapy with imatinib plus interferon alfa in patients with chronic myeloid leukemia. J Clin Oncol. 2010 Mar 10;28(8):1429-35. Epub 2010 Feb 8.

Saussele S, Lauseker M, Gratwohl A, Beelen DW, Bunjes D, Schwerdtfeger R, Kolb HJ, Ho AD, Falge C, Holler E, Schlimok G, Zander AR, Arnold R, Kanz L, Dengler R, Haferlach C, Schlegelberger B, Pfirrmann M, Müller MC, Schnittger S, Leitner A, Pletsch N, Hochhaus A, Hasford J, Hehlmann R; German CML Study Group. Allogeneic hematopoietic stem cell transplantation (allo SCT) for chronic myeloid leukemia in the imatinib era: evaluation of its impact within a subgroup of the randomized German CML Study IV. Blood. 2010 Mar 11;115(10):1880-5. Epub 2009 Nov 18.

ClinicalTrials.gov Identifier:	NCT00055874 History of Changes
Other Study ID Numbers:	CDR0000271424, III-MK-CML-IV, EU-20248
Study First Received:	March 6, 2003
Last Updated:	November 11, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

chronic phase chronic myelogenous leukemia
childhood chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferon-alpha
Interferon Alfa-2a
Cytarabine
Interferons
Imatinib
Hydroxyurea

Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 12, 2012