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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)


Phase 1/Phase 2
15 Years
N/A
Not Enrolling
Both
Acute Undifferentiated Leukemia, B-cell Adult Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, L1 Adult Acute Lymphoblastic Leukemia, L1 Childhood Acute Lymphoblastic Leukemia, L2 Adult Acute Lymphoblastic Leukemia, L2 Childhood Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia, T-cell Adult Acute Lymphoblastic Leukemia, T-cell Childhood Acute Lymphoblastic Leukemia, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia

Thank you

Trial Information

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)


PRIMARY OBJECTIVES:

I. To determine the feasibility and toxicity profiles of escalating doses of Campath-1H
(alemtuzumab) given subcutaneously during post-remission intensification treatment of adults
with acute lymphoblastic leukemia (ALL).

II. To determine the disease-free survival (DFS) and overall survival (OS) when Campath-1H
is used during post-remission intensification treatment of adults with ALL.

III. To determine whether antibody treatment with Campath-1H can further reduce minimal
residual disease states in adult ALL.

IV. To obtain preliminary descriptive data on serum levels of Campath-1H during course IV,
module D using limited pharmacokinetic sampling during the phase I and II components of the
study.

V. To obtain feasibility data on the addition of imatinib to Cancer and Leukemia Group B
(CALGB) induction and postremission combination chemotherapy for patients with Philadelphia
chromosome positive (Ph+) ALL.

OUTLINE: This is a dose-escalation study of alemtuzumab.

COURSE 1 (module A): Patients receive allopurinol orally (PO) 4 times daily (QID) on days
1-14, cyclophosphamide* intravenously (IV) over 15-30 minutes on day 1, daunorubicin
hydrochloride IV on days 1-3, vincristine sulfate IV on days 1, 8, 15, and 22, dexamethasone
PO twice daily (BID) on days 1-7 and 15-21, asparaginase subcutaneously (SC) on days 5, 8,
11, 15, 18, and 22, and filgrastim SC on days 4-11. Patients who are Ph+ also receive
imatinib mesylate PO on days 15-28.

*Note: Patients who are = 60 years old do not receive cyclophosphamide.

COURSE 2 (module B): Patients receive methotrexate intrathecally (IT) on day 1, cytarabine
IV over 3 hours on days 1-3, dexamethasone as eye drops QID on days 1-4,
trimethoprim-sulfamethoxazole PO BID 3 times weekly on days 1-29, and cyclophosphamide,
asparaginase and filgrastim as in course 1. Patients who are Ph+ also receive imatinib
mesylate PO on days 1-28.

COURSE 3 (module C): Patients receive vincristine sulfate IV on days 1, 15, and 29,
methotrexate IV over 3 hours and IT on days 1, 15, and 19, methotrexate PO every 6 hours on
days 1-2, 15-16, and 29-30, mercaptopurine PO on days 1-35, leucovorin calcium IV on days 2,
16, and 30, leucovorin calcium PO every 6 hours on days 3-4, and
trimethoprim-sulfamethoxazole PO BID 3 times weekly on days 1-43. Patients who are Ph+ also
receive imatinib mesylate PO on days 1-42.

COURSE 4 (module D): Patients receive alemtuzumab SC 3 times weekly for 4 weeks and begin
acyclovir PO QID for 6 months (continuing through course 8).

COURSE 5 (module A): Patients repeat course 1, minus allopurinol.

COURSE 6 (module B): Patients repeat course 2.

COURSE 7 (module C): Patients repeat course 3.

COURSE 8: Patients receive mercaptopurine PO, vincristine sulfate IV on day 1, dexamethasone
PO on days 1-5, methotrexate PO on days 1, 8, 15, and 22, and trimethoprim-sulfamethoxazole
PO BID 3 days weekly. Patients who are Ph+ also receive imatinib mesylate PO on days 1-28.
Courses repeat every 28 days for up to 24 months in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 10 years.


Inclusion Criteria:



- Unequivocal histologic diagnosis of precursor B or precursor T lymphoblastic leukemia
(World Health Organization [WHO] classification), L1 or L2 ALL or acute
undifferentiated leukemia (AUL) (French-American-British Cooperative group [FAB]
Classification); Burkitt-type ALL (FAB L3, surface immunoglobulin [SIg]+) are
excluded

- No prior treatment for leukemia with three permissible exceptions:

- Emergency leukapheresis II. Emergency treatment for hyperleukocytosis with
hydroxyurea III. Cranial radiation therapy (RT) for central nervous system (CNS)
leukostasis (one dose only)

- All patients must have a pre-treatment bone marrow or peripheral blood sample
submitted for central immunophenotyping; only those patients who express CD52 >= 10%
in the leukemia blast cell channel will be eligible to receive Campath-1H during
module D, course IV

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of alemtuzumab defined as the highest dose at which less than 40% of patients develop the dose-limiting toxicity (DLT) assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Phase I)

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Wendy Stock

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B (CALGB) Research Base

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02807

NCT ID:

NCT00061945

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Acute Undifferentiated Leukemia
  • B-cell Adult Acute Lymphoblastic Leukemia
  • B-cell Childhood Acute Lymphoblastic Leukemia
  • L1 Adult Acute Lymphoblastic Leukemia
  • L1 Childhood Acute Lymphoblastic Leukemia
  • L2 Adult Acute Lymphoblastic Leukemia
  • L2 Childhood Acute Lymphoblastic Leukemia
  • Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia
  • Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
  • Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia
  • T-cell Adult Acute Lymphoblastic Leukemia
  • T-cell Childhood Acute Lymphoblastic Leukemia
  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Childhood Acute Lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Philadelphia Chromosome
  • Leukemia, Myeloid, Acute

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470