CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 302 enrolled
Drug / intervention
allopurinol +16 moredrug
Likely dose
Not stated in record
Key inclusion· 2
  • Confirmed diagnosis of precursor B or T cell lymphoblastic leukemia (L1 or L2 morphology) or acute undifferentiated leukemia
  • CD52 ≥10% expression on leukemic blast cells required to receive alemtuzumab
Key exclusion· 2
  • Burkitt-type ALL (FAB L3 with surface immunoglobulin positivity)
  • Prior treatment for leukemia except emergency leukapheresis, hydroxyurea for hyperleukocytosis, or CNS-directed radiation (one dose only)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00061945
NCT00061945Phase 2Completed

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)

National Cancer Institute (NCI)·interventional·Posted Jun 6, 2003·Updated May 3, 2022

In Brief

A Phase 2 clinical trial evaluating allopurinol, cyclophosphamide, and 15 other interventions for Acute Undifferentiated Leukemia and 13 related conditions. Completed, enrolled 302 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy also work in different ways to kill cancer cells or stop them from growing. Giving alemtuzumab together with combination chemotherapy may be a better way to block cancer growth.

Study Details

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2003
Enrollment StartJun 1, 2003
Primary CompletionDec 1, 2007
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 23.1 years ago

Interventions

allopurinoldrug

Given PO

cyclophosphamidedrug

Given IV

daunorubicin hydrochloridedrug

Given IV

vincristine sulfatedrug

Given IV

dexamethasonedrug

Given PO and as eye drops

asparaginasedrug

Given SC

filgrastimbiological

Given SC

imatinib mesylatedrug

Given PO

methotrexatedrug

Given IT, IV, and PO

cytarabinedrug

Given IV

trimethoprim-sulfamethoxazoledrug

Given PO

mercaptopurinedrug

Given PO

leucovorin calciumdrug

Given IV and PO

alemtuzumabbiological

Given SC

acyclovirdrug

Given PO

laboratory biomarker analysisother

Correlative studies

pharmacological studyother

Correlative studies