NCT00551460

S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00551460

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination chemotherapy may be more effective in treating promyelocytic leukemia.

PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination chemotherapy works in treating patients with previously untreated promyelocytic leukemia.

Eligibility

DISEASE CHARACTERISTICS:

* Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow examination

* APL-RARα-negative by RT-PCR are not eligible
* High-risk disease, defined as WBC \> 100,000/mm\^3
* Bone marrow specimens must be made available for cytogenetic studies

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prolonged QTc \> 0.47 sec
* No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or stage II cancer from which the patients is currently in complete remission

PRIOR CONCURRENT THERAPY:

* No prior systemic chemotherapy for acute leukemia

* At least 3 days since prior tretinoin (ATRA) allowed
* Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts allowed

Disease(s) and\or Condition(s)

Leukemia

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: arsenic trioxide
- Description:
- Arm Group Labels: Treatment
- Type: DRUG
- Name: gemtuzumab ozogamicin
- Description:
- Arm Group Labels: Treatment
- Type: DRUG
- Name: mercaptopurine
- Description:
- Arm Group Labels: Treatment
- Type: DRUG
- Name: methotrexate
- Description:
- Arm Group Labels: Treatment
- Type: DRUG
- Name: tretinoin
- Description:
- Arm Group Labels: Treatment

Sponsor

SWOG Cancer Research Network