Symptoms and General Pathology

All Conditions

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Blood and Lymph Conditions

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Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Preleukemia

Myelodysplastic Syndromes

Blast Crisis

Leukemia, Lymphoid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

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Lymphatic Diseases

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Neoplastic Processes

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Disease Attributes

Chronic Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Farnesyl Protein Transferase Inhibitor

The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) as a single agent in patients with Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia in Blast Crisis, or Acute Lymphoblastic Leukemia.

Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)

Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia

Merck Sharp & Dohme LLC

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Fludarabine

Fludarabine phosphate

Gemtuzumab

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Fludarabine 15 mg/m\^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m\^2 IV over 2 hours every 12 hours for 5 days.

0.5 grams/m\^2 over 2 hours(+/- 15 minutes) IV every 12 (+/-2) hours for 5 days (4 days in patients \> 65 years and 3 days in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 3).

15 mg/m\^2 to be given IV over 15-30 minutes every 12 (+/- 2) hours for 5 days. (4 days in patients \> 65 years and 3 days in patients with PS \> 3).

Elias Jabbour, MD

The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this drug combination will also be studied.

The Study Drugs Fludarabine is designed to make cancer cells less able to repair damaged DNA (the genetic material of cells). This may increase the likelihood of the cells dying.

Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive fludarabine and cytarabine.

During each cycle (about 4-6 weeks), you will receive the study drugs for up to 5 days and you will be watched by the study staff for about 1 month.

Induction (Cycle 1):

For 3, 4, or 5 days during Days 1-5 of Cycle 1, you will receive fludarabine by vein over 15-30 minutes 2 times a day (about every 12 hours).

For 3, 4, or 5 days during Days 1-5 of Cycle 1, you will receive cytarabine by vein over about 2 hours 2 times a day (about every 12 hours).

If the cancer does not completely respond after Cycle 1, you may repeat induction (Cycle 1).

If the cancer completely responds, you will begin the consolidation cycles.

Consolidation (Cycles 2-7):

For 3 or 4 days during Days 1-4 of Cycles 2-7, you will receive fludarabine by vein over 15-30 minutes 2 times a day (about every 12 hours).

For 3 or 4 days during Days 1-4 of Cycles 2-7, you will receive cytarabine by vein over about 2 hours 2 times a day (about every 12 hours).

Study Visits:

At each study visit, you will be asked about any side effects you may be having and about any other drugs you may be taking.

During Induction Therapy (Cycle 1):

* Blood (about 2 tablespoons) will be drawn for routine tests every 3-7 days.
* About Day 28, you may have a bone marrow aspirate to check the status of the disease.

During Consolidation Therapy (Cycles 2-7):

* Blood (about 2 tablespoons) will be drawn for routine tests every 1-2 weeks.
* You will have a bone marrow aspirate every 2-3 cycles to check the status of the disease.

Length of Study:

You will be able to receive the study drugs for up to about 8 months. You will be taken off study treatment if you have intolerable side effects, if the disease gets worse, or if the study doctor thinks it is in your best interest.

Long-Term Follow-Up:

Every 3 months for 2 years after you are off study treatment, you will be called and asked how you are feeling, about any side effects you may be having, and about another other drugs you may be taking.

Supportive Care:

Please talk with your doctor about drugs that you can or cannot take while you are on study.

This is an investigational study. Cytarabine is FDA approved and commercially available as a frontline (first) treatment for AML. Fludarabine is FDA approved and commercially available for the treatment of CLL.

The combination of these 2 drugs to treat AML, MDS, or CML in myeloid blast crisis is investigational.

Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson.

Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome

Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.

M.D. Anderson Cancer Center

Of the 151 participants registered, four did not recieve treatment and were excluded from adverse event reporting.

Cytarabine + Fludarabine

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Elias Joseph Jabbour MD/Assistant Professor

Of participants enrolled, 147 participants received treatment and were evaluable.

Participants With a Complete Response

Overall Study

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anticoagulants

Other Dietary Supplements

Dexamethasone

Dexamethasone acetate

BB 1101

Citric Acid

Sodium Citrate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Citrate

Single agent TG02 citrate in acute leukemia patients

Single Agent TG02 citrate in multiple myeloma patients

TG02 in combination with carfilzomib and dexamethasone in multiple myeloma patients

TG02 in combination with carfilzomib and dexamethasone in carfilzomib refractory multiple myeloma patients

TG02 citrate

Carfilzomib

T Parrott

This is a multicenter, open-label, dose escalation Phase 1 study.

This is a multicenter, open-label, dose escalation, Phase 1/1b study.

For Parts 1, 2, and 3 of the study, the primary objective is to determine the highest dose of TG02 citrate that can safely be given to patients with different types of hematological malignancy.

For Part 4, the primary objective is to evaluate the safety and tolerability of once-weekly dosing at the maximum-tolerated dose/ Recommended Phase 2 Dose of TG02 in combination with carfilzomib.

This study consists of four parts:

* Part 1: single agent TG02 in acute leukemia patients
* Part 2: single agent TG02 in multiple myeloma patients
* Part 3: TG02 in combination with carfilzomib in multiple myeloma patients
* Part 4: TG02 in combination with carfilzomib in carfilzomib refractory multiple myeloma patients.

Phase 1 Study of TG02 Citrate in Patients With Advanced Hematological Malignancies

Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Advanced Hematological Malignancies

Maximum Tolerated Dose refers to the highest dose of TG02 administered that will produce the desired effect without unacceptable toxicity.

Safety data will include vital signs, ECGs, PE findings, clinical laboratory parameters, ECOG PS, AEs/SAEs and concomitant medications.

Plasma will be analyzed to determine TG02 concentration.

Clinical Benefit Response is defined as the sum of all response categories for Overall Response Rate (ORR is defined as the sum of patients with sCR, CR, VGPR and PR) plus minimal response (MR).

Overall Response Rate is defined as the sum of patients with sCR, CR, VGPR and PR.

Progression-Free Survival is the time to disease progression or death, which is measured from the date of first study drug administration until the first date that recurrent or progressive disease is objectively documented or the date of death.

Overall Survival is time to death, which is measured from the date of first study drug administration until the date of death.

Duration of Response is the duration from first observation of response to the first documentation of disease progression, with deaths from causes other than disease progression censored. For the purposes of the calculation of the DOR, the date at which the response status was first observed rather than the date of confirmation is used as the start date.

Pharmacodynamic sampling may include whole blood and bone marrow at baseline and post-treatment for pathway determination if available.

Tragara Pharmaceuticals, Inc.

Philadelphia Chromosome

Translocation, Genetic

Chromosome Aberrations

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.

imatinib mesylate

Novartis Pharmaceuticals

This extension II study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.

An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis

An Extension to a Phase II Open-label Study to Determine the Safety and Anti-leukemic Effects of STI571 in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Myeloid Blast Crisis

Overall survival was defined as the number of events of death, expressed as a percentage, from the start of treatment to death, due to any reason.

Overall survival was defined as the time between start of treatment and death due to any reason. Overall survival for the participants was calculated by Kaplan-Meier estimates per month. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up.

After 31 July 2002 no safety data was collected in the clinical database and serious adverse events (SAEs) were reported in the safety database. No drug-related SAEs leading to discontinuation or drug-related deaths were reported after 31 July 2002 in the safety database.

Imatinib Mesylate (STI571)

The Intent-to-treat (ITT) population included all participants who enrolled in the study.

Study Director

Overall Survival

12 Months

24 Months

36 Months

48 Months

60 Months

72 Months

84 Months

96 Months

108 Months

120 Months

132 Months

144 Months

156 Months

Overall Survival (by Month)

Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.

Core Study

E2 Extension

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)	NCT00034684	Leukemia Myelodysplastic... Leukemia, Myelo... Blast Crisis Leukemia, Lymph...	Farnesyl Protei...	18 Years -	Merck Sharp & Dohme LLC
Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)	NCT01019317	Leukemia AML MDS CML	Cytarabine Fludarabine	12 Years -	M.D. Anderson Cancer Center
Phase 1 Study of TG02 Citrate in Patients With Advanced Hematological Malignancies	NCT01204164	AML ALL Blast Crisis MDS Multiple Myelom...	TG02 citrate Carfilzomib Dexamethasone	18 Years -	Tragara Pharmaceuticals, Inc.
An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis	NCT00171158	Philadelphia Ch...	imatinib mesyla...	18 Years -	Novartis
An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis	NCT00171158	Philadelphia Ch...	imatinib mesyla...	18 Years -	Novartis

Spots Global Cancer Trial Database for blast crisis

Every month we try and update this database with for blast crisis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.