Cyclophosphamide for Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TXAcute Lymphoblastic Leukemia+1 MoreCyclophosphamide - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a chemotherapy combination with the drug nelarabine to treat T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • T-Cell Lymphoblastic Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: Up to 9 years

3 years
Complete remission rate
Overall survival
Progression-free survival
Up to 9 years
Duration of remission

Trial Safety

Safety Progress

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%.

Trial Design

1 Treatment Group

Treatment (nelarabine and combination chemotherapy)
1 of 1

Experimental Treatment

160 Total Participants · 1 Treatment Group

Primary Treatment: Cyclophosphamide · No Placebo Group · Phase 2

Treatment (nelarabine and combination chemotherapy)Experimental Group · 11 Interventions: Nelarabine, Prednisone, Cyclophosphamide, Cytarabine, Dexamethasone, Methotrexate, Doxorubicin Hydrochloride, Pegaspargase, Mercaptopurine, Venetoclax, Vincristine Sulfate · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nelarabine
FDA approved
Prednisone
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved
Dexamethasone
FDA approved
Methotrexate
FDA approved
Doxorubicin
FDA approved
Pegaspargase
FDA approved
Mercaptopurine
FDA approved
Venetoclax
FDA approved
Vincristine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 9 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,825 Previous Clinical Trials
1,792,411 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,764 Total Patients Enrolled
Farhad Ravandi-KashaniPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
395 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

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