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Clinical Trials (PDQ®)

Phase III Randomized Trial of G-CSF vs Placebo During Induction and Consolidation Chemotherapy for Adult ALL (Summary Last Modified 09/91)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed15 and overNCICLB-9111
CALGB-9111

Objectives

I.  Compare time to bone marrow recovery, incidence of infection, days of 
hospitalization, and tolerance of nonhematopoietic organs following intensive 
chemotherapy for ALL in patients randomized to receive granulocyte colony 
stimulating factor (G-CSF) vs. placebo.
II.  Determine the effect of G-CSF on the rate and duration of CR and on the 
incidence of death during neutropenia in patients treated with the current 
CALGB intensive 5-drug induction regimen and intensive consolidation program 
(protocol CLB-8811).
III.  Compare the dose intensity of chemotherapy that can be delivered to 
patients receiving G-CSF vs. placebo during the first 3 months of treatment.
IV.  Continue to investigate the prognostic signifigance for survival of the 
following disease and patient characteristics:  immunophenotype, especially 
My+ antigens; cytogenetics, especially Ph1, T(8;14), and t(4;11); molecular 
analyses; entry age; leukocyte and platelet counts; and mediastinal mass, 
organomegaly, and lymphadenopathy.
V.  Continue to examine the prognostic significance of the day 7 bone marrow 
examination.

Entry Criteria

Disease Characteristics:


Unequivocal diagnosis of ALL, FAB classification L1-L3

  Cytochemical/immunological studies must be consistent with
  diagnosis of ALL

Patients with acute undifferentiated leukemia with negative
myeloperoxidase or Sudan black reactivity and lacking myeloid
antigens are also eligible

Simultaneous entry on CLB-8364 (immunology) required; patient
remains eligible for CLB-9111 even if bone marrow samples are
inadequate for CLB-8364

Entry on CLB-8461 (cytogenetics), CLB-8762 (molecular
subtypes in Ph1+ ALL), and CLB-8763 (Ig and TCR gene
rearrangements in ALL) is strongly encouraged


Prior/Concurrent Therapy:


Biologic therapy:
  No prior treatment, including hematopoietic growth factors

Chemotherapy:
  No prior treatment except emergency hydroxyurea for up to
  72 hours for rapidly progressive hyperleukocytosis

Endocrine therapy:
  No prior treatment

Radiotherapy:
  No prior treatment except a single dose of radiation for
  CNS leukocytosis

Surgery:
  No prior treatment


Patient Characteristics:


Age:
  15 years and older

Performance status:
  Not specified

Life expectancy:
  At least 2 years (aside from malignancy)

Hematopoietic:
  Confirmed diagnosis of ALL or AUL

Hepatic:
  Total bilirubin less than 1.5 x normal

Renal:
  Creatinine less than 1.5 x normal

Cardiovascular:
  No MI within 6 months
  No CHF
  No other uncontrolled or severe cardiovascular disease

Other:
  No active uncontrolled bacterial, viral, or fungal
  infection or active duodenal ulcer until such conditions
  are corrected or controlled

  No other serious medical condition that would limit
  survival to less than 2 years

  No psychiatric condition that would interfere with informed
  consent or protocol compliance

  No second malignancy within the past 5 years except:
     Curatively treated in situ cervical cancer
     Basal cell skin cancer

Management throughout entire duration of protocol treatment
must be effected at a facility with ready access to blood
product support and adequately staffed to care for severe
neutropenia and other severe toxicities


Expected Enrollment

150 patients will be randomized over about 2 years.

Outline

Randomized, double-blind study.  Following Induction, the study is unblinded; 
Arm I Induction patients continue to receive G-CSF during Intensification, 
while Arm II Induction patients do not continue to receive placebo.  
Otherwise, treatment of medullary disease is the same for all patients 
following Induction.
Gonadal irradiation for patients who develop testicular ALL during remission 
(on or off protocol therapy) is described under Regimen A; patients with 
testicular ALL at presentation begin treatment on Regimen A if their gonadal 
disease persists or worsens at the end of Induction.
Treatment of CNS leukemia is described under Regimen B.
Induction:
Arm I:  5-Drug Combination Chemotherapy plus Hematopoietic Growth Factor 
Therapy.  Cyclophosphamide, CTX, NSC-26271; Daunorubicin, DNR, NSC-82151; 
Vincristine, VCR, NSC-67574; Prednisone, PRED, NSC-10023; Asparaginase, ASP, 
NSC-109229; plus Granulocyte Colony Stimulating Factor (Amgen), G-CSF, 
NSC-614629.
Arm II:  5-Drug Combination Chemotherapy plus Placebo.  CTX; DNR; VCR; PRED; 
ASP; plus Placebo.
Intensification:  5-Drug Combination Systemic Chemotherapy plus (Arm I 
Induction patients only) Hematopoietic Growth Factor Therapy plus Single-agent 
Intrathecal Chemotherapy.  CTX; Cytarabine, ARA-C, NSC-63878; Mercaptopurine, 
MP, NSC-755; VCR; ASP; plus (Arm I Induction patients only) G-CSF; plus 
Intrathecal Methotrexate, IT MTX, NSC-740.
Interim Maintenance/CNS Prophylaxis:  2-Drug Combination Systemic Chemotherapy 
plus Single-agent Intrathecal Chemotherapy plus Radiotherapy.  MP; MTX; plus 
IT MTX; plus whole-brain irradiation using Co60 equipment or photons with 
energies of 4-6 MeV.
Late Intensification:  6-Drug Combination Chemotherapy.  Doxorubicin, DOX, 
NSC-123127; VCR; CTX; Dexamethasone, DM, NSC-34521; ARA-C; Thioguanine, TG, 
NSC-752.
Maintenance:  4-Drug Combination Chemotherapy.  MP; MTX; VCR; PRED.
Regimen A (Treatment of Gonadal Disease):  Radiotherapy.  Bilateral testicular 
irradiation using Co60 or x-rays with energies of 4-6 MeV.
Regimen B (Treatment of CNS Disease):  Radiotherapy plus Single-agent 
Intrathecal Chemotherapy with Leucovorin Rescue.  Whole-brain irradiation 
using Co60 or photons with energies of 4-6 MeV; plus IT MTX; with Leucovorin 
calcium, CF, NSC-3590.

Published Results

Larson RA, Linker CA, Dodge RK, et al.: Granulocyte-colony stimulating factor (filgrastim; G-CSF) reduces the time to neutrophil recovery in adults with acute lymphoblastic leukemia receiving intensive remission induction chemotherapy: Cancer and Leukemia Group B study 9111. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-995, 305, 1994.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Richard Larson, MD, Protocol chair
Ph: 773-702-6783; 888-824-0200

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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