Ignite Creation Date:
2024-05-06 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03672539
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2018-09-10
Brief Title:
Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia AML or High Risk Myelodysplastic Syndrome
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Study of Liposomal Cytarabine and Daunorubicin CPX-351 in Combination With Gemtuzumab Ozogamicin GO in Relapsed Refractory Patients With Acute Myeloid Leukemia AML and Post-Hypomethylating Agent Post-HMA Failure High-Risk Myelodysplastic Syndrome HR-MDS
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This phase II trial studies the side effects and how well liposome-encapsulated daunorubicin-cytarabine and gemtuzumab ozogamicin work in treating patients with acute myeloid leukemia that has come back relapsed or that does not respond to treatment refractory or high risk myelodysplastic syndrome Drugs used in chemotherapy such as liposome-encapsulated daunorubicin-cytarabine work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Gemtuzumab ozogamicin is a monoclonal antibody called gemtuzumab linked to a toxic agent called calicheamicin Gemtuzumab ozogamicin attached to CD33 positive cancer cells in a targeted way and delivers calicheamicin to kill them Giving liposome-encapsulated daunorubicin-cytarabine and gemtuzumab ozogamicin together may be an effective treatment for relapsed or refractory acute myeloid leukemia or high risk myelodysplastic syndrome
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety of liposome-encapsulated daunorubicin-cytarabine liposomal cytarabine and daunorubicin CPX-351 in combination with gemtuzumab ozogamicin GO in relapsed refractory R-R patients with acute myeloid leukemia AML and post-hypomethylating agent post-HMA failure high-risk myelodysplastic syndrome HR-MDS
II To determine the efficacy of liposomal cytarabine and daunorubicin CPX-351 in combination with gemtuzumab ozogamicin GO in relapsed refractory patients with acute myeloid leukemia AML and post-hypomethylating agent post-HMA failure high-risk myelodysplastic syndrome HR-MDS
SECONDARY OBJECTIVE
I To determine the preliminary assessment of efficacy by response to revised International Working Group IWG criteria and time to response variables including overall survival OS event-free survival EFS and duration of response DOR of patients treated with this combination
EXPLORATORY OBJECTIVES
I To determine the minimal residual disease MRD after treatment with this combination and its impact in long-term outcome
II To determine the effect of the level of pre-treatment expression of CD33 with response to this combination
III To determine the baseline CD33 genotype via CD33 polymorphism study and its effect on response to this combination
IV To determine the effect of this treatment combination on responding patients transitioning to hematopoietic stem cell transplantation HSCT
V To evaluate the effect of the treatment combination on Health Related Quality of Life HRQoL parameters
OUTLINE
INDUCTION CYCLE Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously IV over 90 minutes on days 1 3 and 5 of cycle 1 and days 1 and 3 of cycle 2 and gemtuzumab ozogamicin IV over 120 minutes on day 1 Treatment repeats every 28 days for up to 2 cycles in the absence of unacceptable toxicity
CONSOLIDATION CYCLE Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 and gemtuzumab ozogamicin over 120 minutes on day 1 Treatment repeats every 28 days for up to 2 cycles in the absence of unacceptable toxicity
MAINTENANCE CYCLE Patients receive gemtuzumab ozogamicin IV over 120 minutes on day 1 Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 14 months
I To determine the safety of liposome-encapsulated daunorubicin-cytarabine liposomal cytarabine and daunorubicin CPX-351 in combination with gemtuzumab ozogamicin GO in relapsed refractory R-R patients with acute myeloid leukemia AML and post-hypomethylating agent post-HMA failure high-risk myelodysplastic syndrome HR-MDS
II To determine the efficacy of liposomal cytarabine and daunorubicin CPX-351 in combination with gemtuzumab ozogamicin GO in relapsed refractory patients with acute myeloid leukemia AML and post-hypomethylating agent post-HMA failure high-risk myelodysplastic syndrome HR-MDS
SECONDARY OBJECTIVE
I To determine the preliminary assessment of efficacy by response to revised International Working Group IWG criteria and time to response variables including overall survival OS event-free survival EFS and duration of response DOR of patients treated with this combination
EXPLORATORY OBJECTIVES
I To determine the minimal residual disease MRD after treatment with this combination and its impact in long-term outcome
II To determine the effect of the level of pre-treatment expression of CD33 with response to this combination
III To determine the baseline CD33 genotype via CD33 polymorphism study and its effect on response to this combination
IV To determine the effect of this treatment combination on responding patients transitioning to hematopoietic stem cell transplantation HSCT
V To evaluate the effect of the treatment combination on Health Related Quality of Life HRQoL parameters
OUTLINE
INDUCTION CYCLE Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously IV over 90 minutes on days 1 3 and 5 of cycle 1 and days 1 and 3 of cycle 2 and gemtuzumab ozogamicin IV over 120 minutes on day 1 Treatment repeats every 28 days for up to 2 cycles in the absence of unacceptable toxicity
CONSOLIDATION CYCLE Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 and gemtuzumab ozogamicin over 120 minutes on day 1 Treatment repeats every 28 days for up to 2 cycles in the absence of unacceptable toxicity
MAINTENANCE CYCLE Patients receive gemtuzumab ozogamicin IV over 120 minutes on day 1 Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 14 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2018-0235 | OTHER | M D Anderson Cancer Center | None |
| NCI-2018-01812 | REGISTRY | None | None |