Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia - Full Text View

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00061945

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab and to see how well it works when given together with combination chemotherapy in patients with previously untreated acute lymphoblastic leukemia.

Condition	Intervention	Phase
Leukemia	Biological: alemtuzumab Biological: filgrastim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: vincristine sulfate	Phase I Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Dexamethasone Cyclophosphamide 6-Mercaptopurine Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Citrovorum factor Dexamethasone acetate Doxiproct plus Filgrastim Campath Imatinib Alemtuzumab Imatinib mesylate Cytarabine Leucovorin Calcium Dexamethasone Sodium Phosphate Vincristine sulfate Folinic acid calcium salt pentahydrate Mercaptopurine L-Asparaginase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I/II Dose Escalation Study of Subcutaneous Campath-1H (NSC #715969, IND #10864) During Intensification Therapy in Adults With Untreated Acute Lymphoblastic Leukemia (ALL)

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

Primary Outcome Measures:

Maximum tolerated dose of alemtuzumab as measured by CTC version 3.0 (Phase I) [ Designated as safety issue: Yes ]
Feasibility and toxicity profile (including dose-limiting toxicity) (Phase II) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Designated as safety issue: No ]
Toxicity profile as measured by CTC version 3.0 (Phase II) [ Designated as safety issue: Yes ]
Correlation of antibody treatment with alemtuzumab and modulation of minimal residual disease (Phase II) [ Designated as safety issue: No ]
Disease-free survival (DFS) (Phase II) [ Designated as safety issue: No ]
Overall survival (OS) (Phase II) [ Designated as safety issue: No ]

Estimated Enrollment:	282
Study Start Date:	June 2003
Estimated Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed precursor B- or T-lymphoblastic leukemia, L1 or L2 acute lymphoblastic leukemia (ALL), or acute undifferentiated leukemia
No Burkitt-type ALL
No prior treatment for leukemia except for any of the following:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
- Cranial radiotherapy for CNS leukostasis (1 dose only)
Must have a pretreatment bone marrow or peripheral blood sample submitted for central immunophenotyping
- Only patients who express CD52 at least 10% in the leukemic blast cell channel are eligible to receive alemtuzumab during module D, course IV
Must be entered on CLB 9665, 9862, and 8461

PATIENT CHARACTERISTICS:

Age

15 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
- No nursing for at least 3 months after study therapy
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics

Chemotherapy

See Disease Characteristics
No other concurrent chemotherapy

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
No concurrent palliative radiotherapy
- Concurrent whole brain radiotherapy allowed for documented CNS disease

Surgery

Not specified

Other

No concurrent alcoholic beverages
No concurrent over-the-counter pain relievers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061945

Show 35 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Wendy Stock, MD

University of Chicago

More Information

Additional Information:

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

Publications:

Lozanski G, Sanford B, Mrozek K, et al.: Quantitative measurement of CD52 expression and alemtuzumab binding in adult acute lymphoblastic leukemia (ALL): correlation with immunophenotype and cytogenetics in patients (pts) enrolled on a phase I/II trial from the Cancer and Leukemia Group B (CALGB 10102). [Abstract] Blood 110 (11): A-2386, 2007.

Stock W, Yu D, Sanford B, et al.: Incorporation of alemtuzumab into front-line therapy of adult acute lymphoblastic leukemia (ALL) is feasible: a phase I/II study from the Cancer and Leukemia Group B (CALGB 10102). [Abstract] Blood 106 (11): A-145, 2005.

Study ID Numbers:	CDR0000302482, CALGB-10102
Study First Received:	June 5, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00061945 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

B-cell adult acute lymphoblastic leukemia
L1 adult acute lymphoblastic leukemia
L2 adult acute lymphoblastic leukemia

T-cell adult acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
acute undifferentiated leukemia

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Antimetabolites
Daunorubicin
Leukemia, Lymphoid
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Leucovorin
6-Mercaptopurine
Cyclophosphamide
Protein Kinase Inhibitors
Hormones
Anti-Bacterial Agents

Leukemia
Vitamins
Alemtuzumab
Methotrexate
Micronutrients
Alkylating Agents
Lymphoma
Dexamethasone acetate
Cytarabine
Acute Lymphoblastic Leukemia
Asparaginase
Vitamin B Complex
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Antineoplastic Agents, Hormonal

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Protein Kinase Inhibitors
Hormones
Alemtuzumab
Therapeutic Uses
Abortifacient Agents
Methotrexate

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Imatinib
Neoplasms
Antineoplastic Agents, Phytogenic
Antimetabolites
Daunorubicin

ClinicalTrials.gov processed this record on May 06, 2009