CLINICAL TRIAL

Doxorubicin for Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether a combination of chemotherapy and dasatinib is more effective than chemotherapy alone in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia.

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About the trial for Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Eligible Conditions
Recurrent Acute Lymphoblastic Leukemia · Blast Crisis · BCR-ABL1 Fusion Protein Expression · Leukemia, Myeloid · Leukemia, Lymphoid · Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Philadelphia Chromosome · Leukemia · Acute Lymphoblastic Leukemia (ALL) · Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive · Philadelphia Chromosome Positive · t(9;22) · Precursor Cell Lymphoblastic Leukemia-Lymphoma

Treatment Groups

This trial involves 2 different treatments. Doxorubicin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Doxorubicin
DRUG
Vincristine
DRUG
Cyclophosphamide
DRUG
Cytarabine
DRUG
Prednisone
DRUG
Methotrexate
DRUG
Dexamethasone
DRUG
Dasatinib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin
FDA approved
Vincristine
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved
Cortisone
Not yet FDA approved
Methotrexate
FDA approved
Dexamethasone
FDA approved
Dasatinib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Myelogenous, Chronic, BCR-ABL Positive or one of the other 12 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
will be treated with imatinib mesylate (Gleevec) Previously untreated Ph-positive acute lymphoblastic leukemia (ALL) (either t(9;22) and/or BCR-ABL positive) After 1-2 courses of chemotherapy with or without imatinib mesylate (Gleevec) show original
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 means that a person is able to walk and perform light activities. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: The time from treatment until any failure (resistant disease, relapse, or death), assessed up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: The time from treatment until any failure (resistant disease, relapse, or death), assessed up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Doxorubicin will improve 2 primary outcomes and 3 secondary outcomes in patients with Leukemia, Myelogenous, Chronic, BCR-ABL Positive. Measurement will happen over the course of The time from documented complete response (CR) until relapse or death, assessed up to 12 months.

Disease-free survival
THE TIME FROM DOCUMENTED COMPLETE RESPONSE (CR) UNTIL RELAPSE OR DEATH, ASSESSED UP TO 12 MONTHS
The results will be compared descriptively to historical controls in terms of response, survival, toxicity, etc. (recently published data). A 95% confidence interval width will be approximated.
Overall survival
UP TO 12 MONTHS
Overall response rate
UP TO 12 MONTHS
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
UP TO 12 MONTHS
Event-free survival rate
THE TIME FROM TREATMENT UNTIL ANY FAILURE (RESISTANT DISEASE, RELAPSE, OR DEATH), ASSESSED UP TO 2 YEARS
The results will be compared descriptively to historical controls in terms of response, survival, toxicity, etc. (recently published data). A 95% confidence interval width will be approximated.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is leukemia, myelogenous, chronic, bcr-abl positive?

Approximately 1 million people die each year from this disorder which is the most common type of leukemia. In most cases leukaemia, myelogenous, chronic, bcr-abl positive is responsive to treatment.

Anonymous Patient Answer

What causes leukemia, myelogenous, chronic, bcr-abl positive?

This population-based case-control study (of Caucasian-Americans) did not confirm previous results on CML. The association of CML with familial risk factors could reflect the role of environment in influencing this malignancy.

Anonymous Patient Answer

What are the signs of leukemia, myelogenous, chronic, bcr-abl positive?

The only definitive sign is a leukocytosis, which is more commonly present in AML. Other signs may be present in a mixed-crisis leukemia, such as splenomegaly or lymphadenopathy, but definitive detection only occurs with diagnostic tests such as an immunophenotype or cytogenetic profiling. Other signs are usually subtle or nonspecific and are usually present in ALL and/or AML (i.e., fatigue due to treatment or low red blood cell volume).

Anonymous Patient Answer

Can leukemia, myelogenous, chronic, bcr-abl positive be cured?

The presence of leukemia, myelogenous, chronic, bcr-abl positive is an independent risk factor for progression to leukemia-associated or -related death. The treatment of patients with this particular disease is associated with an improved prognosis and the potential for cure or long-term remission. On the basis of these results, and in view of the high incidence and mortality associated with leukemia and/or myelogenous chronic, bcr-abl positive disease in a given geographic area, we recommend that patients with leukemia, myelogenous, chronic, bcr-abl positive disease should be treated within a specific program of structured chemotherapy.

Anonymous Patient Answer

What are common treatments for leukemia, myelogenous, chronic, bcr-abl positive?

Survival rates have increased dramatically throughout the past decade due to advances in multimodal therapy, and the use of imatinib mesylate has been integral to this progress. In addition to improving the quality of life of patients with [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) as well as other malignancies, this agent is being proposed as a targeted therapy in the treatment of acute myeloid leukemia patients with the Philadelphia chromosome. We are encouraged to take all of these drugs cautiously and monitor patients closely using routine laboratory examinations, blood counts, and routine imaging to detect the onset of toxic effects, which can have major impact on disease outcomes.

Anonymous Patient Answer

How many people get leukemia, myelogenous, chronic, bcr-abl positive a year in the United States?

Approximately 21,000 people in the United States are diagnosed with CML a year. The number of people diagnosed with this disease as of 2000 is estimated to be between 6,000 and 12,000.

Anonymous Patient Answer

Have there been any new discoveries for treating leukemia, myelogenous, chronic, bcr-abl positive?

As of now, there are no new treatments for leukemia, myelogenous, chronic, bcr-abl positive patients. Further research is needed to find treatments for leukemia, myelogenous, chronic, bcr-abl positive patients. The American Society of Hematology (ASH) holds the [Blood Disorders Research Conference every two years] to present new research into different aspects of leukemia. These new treatments should improve the success of cancer treatment for persons with leukemia, myelogenous, chronic, bcr-abl positive.

Anonymous Patient Answer

What is the latest research for leukemia, myelogenous, chronic, bcr-abl positive?

The most exciting breakthroughs for treating refractory chronic myeloid leukemia and CML were seen in the last decade, with new therapies including imatinib and thalidomide. More recently, the development of new therapies using thalidomide and more broadly the use of bortezomib and lenalidomide has further improved outcomes. These advancements in treatment regimens have led to a dramatic improvement of the overall survival in many patients. In the current era of targeted therapy, the use of cytogenetic or molecular markers to stratify risk or to evaluate response to therapy has significantly impacted the overall survival.

Anonymous Patient Answer

What are the common side effects of doxorubicin?

We found that more than 30 percent of patients in our study experienced the adverse effects of doxorubicin. Moreover, doxorubicin caused grade I/II adverse effects frequently in this subgroup of patients. The most common side effect was cardiotoxicity. If chemotherapy including doxorubicin is administered, patients must be alert for the signs and symptoms of chemotherapy-related cardiotoxicity.

Anonymous Patient Answer

What does doxorubicin usually treat?

The majority of patients with AML and chronic myelogenous leukemia have very high rates of in vitro resistance to doxorubicin. To the authors' knowledge the therapeutic equivalence of doxorubicin to other anthracyclin-based regimens has not been established. The authors are committed to use anthracyclin-based chemotherapy in the management of these patients, and this therapy has been demonstrated to be active in advanced adult acute myelogenous leukemia and acute promyelocytic leukemia.

Anonymous Patient Answer

What is doxorubicin?

The anticancer agent doxorubicin is a member of the anthracycline family, which includes daunorubicin, doxorubicin hydrochloride and idarubicin. Doxorubicin hydrochloride is the drug for which the clinical application is most pronounced. The molecular structure of doxorubicin is shown in figure (1).\nDoxorubicin is a natural product with a dextro-conformation, as is shown by a double bond at carbon 10. The carbon atom in position 6 is stereogenic, leading to a stereogenic center at carbon 6, as shown for carbon 10.

Anonymous Patient Answer

Has doxorubicin proven to be more effective than a placebo?

Doxorubicin (100 mg/m(2)) is not more effective than a placebo in terms of reduction of the rate of tumor recurrence in patients with chronic myelogenous leukemia.

Anonymous Patient Answer
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