Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003545
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
1999-11-01
Brief Title:
506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of 506U78 in Patients With Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia ALL or Lymphoblastic Lymphomas LBL
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the complete and partial remission rates as well as the remission duration in patients with refractory or relapsed T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma receiving 506U78 on an alternate day schedule days 1 3 5
II Determine the safety and toxicity of 506U78 administered on this schedule to this patient population
OUTLINE
Patients receive 506U78 IV over 2 hours on days 1 3 and 5 If residual leukemialymphoma is present on day 22 then patients receive a second course of 506U78 If day 22 marrow is hypocellular then a repeat bone marrow biopsy should be obtained on day 29 to assess response For day 22 or 29 marrow that is in complete response patients receive 506U78 for two more courses on days 1 3 and 5 administered every 21 days Patients are followed every 3 month for 1 year then every 6 months for a maximum of 10 years
I Determine the complete and partial remission rates as well as the remission duration in patients with refractory or relapsed T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma receiving 506U78 on an alternate day schedule days 1 3 5
II Determine the safety and toxicity of 506U78 administered on this schedule to this patient population
OUTLINE
Patients receive 506U78 IV over 2 hours on days 1 3 and 5 If residual leukemialymphoma is present on day 22 then patients receive a second course of 506U78 If day 22 marrow is hypocellular then a repeat bone marrow biopsy should be obtained on day 29 to assess response For day 22 or 29 marrow that is in complete response patients receive 506U78 for two more courses on days 1 3 and 5 administered every 21 days Patients are followed every 3 month for 1 year then every 6 months for a maximum of 10 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066600 | OTHER_GRANT | PDQ Physician Data Query | None |
| CLB-19801 | None | None | None |
| SWOG-C19801 | None | None | None |