Cyclophosphamide for Chronic Myelogenous Leukemia

M D Anderson Cancer Center, Houston, TX
Chronic Myelogenous Leukemia+6 More ConditionsCyclophosphamide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a combination of drugs to treat leukemia and measure any side effects.

Eligible Conditions
  • Chronic Myelogenous Leukemia (CML)
  • Chronic Myeloid Leukemia (CML)
  • Acute Lymphoblastic Leukemia
  • Adult Acute Lymphoblastic Leukemia in Complete Remission
  • Philadelphia Chromosome Positive

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 24 months

Month 24
Event-free survival
Up to 24 months
Incidence of grade 3-4 toxicity according to the M.D. Anderson Leukemia-specific Adverse Event Recording and Reporting Guidelines
Month 24
Complete response rate
Disease-specific survival
Overall survival

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

Saline
47%Anemia
41%Nausea
31%Lymphocyte count decreased
28%Fatigue
28%Neutrophil count decreased
28%White blood cell decreased
13%Headache
13%Hypoatremia
13%Platelet count decreased
13%Constipation
13%Paresthesia
9%Cough
9%Alanine aminotransferase increased
9%Hypocalcemia
9%Hypokalemia
9%Myalgia
9%Vomiting
9%Hypoalbuminemia
6%Febrile neutropenia
6%Hypernatremia
6%Mucositis oral
6%Pain
6%Chills
6%Dyspnea
6%Edema Limbs
6%Flank Pain
6%Insomnia
3%Fibrinogen decreased
3%Gastritis
3%Depression
3%Hypomagnesemia
3%Hypotension
3%Non-cardiac chest pain
3%Pain in extremity
3%Palpitations
3%Pruritus
3%Sore Throat
3%Vaginal Infection
3%Wheezing
3%Blurred Vision
3%MRSA positive infection in toe
3%Alkaline phosphatase increased
3%Blood bilirubin increased
3%Allergic rhinitis
3%Anorexia
3%Lung Infection
3%Arthralgia
3%Dermatitis
3%Creatinine increased
3%Diarrhea
3%Esophageal Spasms
3%Hemorrhoids
3%Hyperglycemia
3%Lip Infection
3%Muscle weakness upper limb
3%Rash maculo-papular
3%Urinary Frequency
This histogram enumerates side effects from a completed 2015 Phase 2 trial (NCT01205503) in the Saline ARM group. Side effects include: Anemia with 47%, Nausea with 41%, Lymphocyte count decreased with 31%, Fatigue with 28%, Neutrophil count decreased with 28%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.

Trial Design

1 Treatment Group

Treatment (combination chemotherapy, ponatinib hydrochloride)
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Cyclophosphamide · No Placebo Group · Phase 2

Treatment (combination chemotherapy, ponatinib hydrochloride)Experimental Group · 13 Interventions: Dexamethasone, Ponatinib Hydrochloride, Cytarabine, Ponatinib, Doxorubicin, Vincristine Sulfate, Cyclophosphamide, Laboratory Biomarker Analysis, Doxorubicin Hydrochloride, Methotrexate, Prednisone, Vincristine, Rituximab · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Other, Drug, Drug, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Ponatinib
FDA approved
Cytarabine
FDA approved
Ponatinib
FDA approved
Daunorubicin
FDA approved
Vincristine
FDA approved
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Methopterin
Not yet FDA approved
Cortisone
Not yet FDA approved
Vincristine
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,849 Previous Clinical Trials
1,793,425 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
15 Previous Clinical Trials
970 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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