CLINICAL TRIAL

Peripheral Blood Stem Cell Transplantation for Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

1 Prior Treatment
Relapsed
Stage I
Waitlist Available · 18 - 65 · All Sexes · Logan, UT

This study is evaluating the side effects of giving chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia.

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About the trial for Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Eligible Conditions
Precursor Cell Lymphoblastic Leukemia-Lymphoma · Adult B Acute Lymphoblastic Leukemia · Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · Acute Lymphoblastic Leukemia (ALL) · Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 · L1 Adult Acute Lymphoblastic Leukemia · L2 Adult Acute Lymphoblastic Leukemia · Recurrent Adult Acute Lymphoblastic Leukemia (ALL) · Adult T Acute Lymphoblastic Leukemia · Leukemia · Leukemia, Lymphoid

Treatment Groups

This trial involves 2 different treatments. Peripheral Blood Stem Cell Transplantation 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.
Peripheral Blood Stem Cell Transplantation
PROCEDURE
Allogeneic Hematopoietic Stem Cell Transplantation
PROCEDURE
Leucovorin Calcium
DRUG
Prednisone
DRUG
Cyclophosphamide
DRUG
Cytarabine
DRUG
Dexamethasone
DRUG
Methotrexate
DRUG
Dasatinib
DRUG
Etoposide
DRUG
Laboratory Biomarker Analysis
OTHER
Sirolimus
DRUG
Vincristine Sulfate
DRUG
Tacrolimus
DRUG
Methylprednisolone
DRUG
Filgrastim
BIOLOGICAL
Total-Body Irradiation
RADIATION
Doxorubicin Hydrochloride
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
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1970
Allogeneic Hematopoietic Stem Cell Transplantation
2015
Completed Phase 2
~1180
Levoleucovorin
FDA approved
Methylprednisolone
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved
Dexamethasone
FDA approved
Methopterin
Not yet FDA approved
Dasatinib
FDA approved
Beta-D-Glucose
Not yet FDA approved
Sirolimus
FDA approved
Vincristine
FDA approved
Tacrolimus
FDA approved
Methylprednisolone
FDA approved
Filgrastim
FDA approved
Total-Body Irradiation
1997
Completed Phase 3
~1220
Doxorubicin
FDA approved

Eligibility

This trial is for patients born any sex between 18 and 65 years old. You must have received 1 prior treatment for Precursor T-Cell Lymphoblastic Leukemia-Lymphoma or one of the other 10 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients with ALL must have evidence of the disease in their bone marrow and/or blood in order to be eligible for this study show original
For all patients, immunophenotyping of the blood or marrow lymphoblasts must be performed in order to determine lineage (B cell, T-cell, or mixed B/T cell) show original
Patients who have received any induction chemotherapy (treatment prior to registration) for ALL that was not completed more than 28 days prior to registration are not eligible show original
If the patient has been initiated on the hyper-CVAD regimen without a tyrosine kinase inhibitor before the Philadelphia chromosome (Ph)/BCR-ABL status was known, the patient may be registered on the protocol and start dasatinib; in this first course, dasatinib will be administered up to day 14 (if the patient is registered on day 5 and starts therapy on day 6, only 8 days of dasatinib will be administered and dasatinib will be completed on day 14). show original
Patients must have serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and/or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) levels =< 3.0 x IULN within 14 days prior to registration; if both tests are done then both values must be =< 3.0 x IULN. show original
Previously treated patients must contact the study chair before registration to determine the regimen to be given in the first course of induction/consolidation therapy, based on prior therapy. show original
In order to be eligible to participate in the study, patients must have a bilirubin level of 3.0 or less, as compared to the institutional upper limit of normal, within 14 days prior to registration. show original
At least six weeks must have passed since any monoclonal antibodies were given show original
The patient must have a disease that is progressing rapidly, as determined by institutional guidelines. show original
Patients must have Philadelphia chromosome positive leukemia as confirmed by standard cytogenetics, fluorescent in situ hybridization (FISH), and/or polymerase chain reaction (PCR) testing 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: Up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 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 Peripheral Blood Stem Cell Transplantation will improve 1 primary outcome, 1 secondary outcome, and 2 other outcomes in patients with Precursor T-Cell Lymphoblastic Leukemia-Lymphoma. Measurement will happen over the course of 12 months.

Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
12 MONTHS
Will be estimated using the method of Kaplan-Meier.
12 MONTHS
Continuous Complete Remission (CCR) Rate
18 MONTHS
Will be testing using an exact binomial test
18 MONTHS
Overall Survival (OS)
FROM THE DATE OF INITIAL REGISTRATION ON THE STUDY UNTIL DEATH FROM ANY CAUSE, ASSESSED UP TO 5 YEARS
OS will be estimated using the method of Kaplan-Meier.
FROM THE DATE OF INITIAL REGISTRATION ON THE STUDY UNTIL DEATH FROM ANY CAUSE, ASSESSED UP TO 5 YEARS
MRD as Assessed Using Real-time Quantitative Polymerase Chain Reaction and Flow Cytometry
UP TO 5 YEARS
Correlation between the two measures of MRD measured on the same remission specimens will be examined using scatterplots and correlation analysis. The prognostic effect for relapse of each measure will be illustrated using cumulative incidence plots, and estimated using Cox regression models. This outcome will be reported as funding allows.
UP TO 5 YEARS

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 are the signs of precursor t-cell lymphoblastic leukemia-lymphoma?

The most common sign of these diseases is a low platelet count; other frequent signs include fatigue, night sweats and an elevated lactic dehydrogenase. Rarely, there may be jaundice and enlargement of the liver.\n\nThe signs of precancerous diseases of the breast are usually less than a month apart, for example:\n- A lump in a lump\n- A change in the size or shape of the breast\n- A change in the size or shape of the nipple\n- A change in the skin over the breast.

Anonymous Patient Answer

What is precursor t-cell lymphoblastic leukemia-lymphoma?

Precursor t-cell lymphoblastic leukemia-lymphoma is a group of high-risk B-cell precursor leukemias that are classified by abnormal cells and immunophenologic and cytogenetic parameters. As a rule, B-cells have light blue nuclear chromatin, which has no relationship with the morphology of the leukemic cells. Precursor t-cell lymphoblastic leukemia-lymphoma is characterized by a B-cell precursor leukemic clone that expresses c-lymphoblastic leukemia-associated (c-Tac) protein, is not associated with other leukemic blasts, and occurs in patients with certain hematologic disorders or with immunodeficiency syndromes.

Anonymous Patient Answer

What are common treatments for precursor t-cell lymphoblastic leukemia-lymphoma?

Rarely, precursor t-cell lymphoblastic leukemia-lymphoma can be treated with CHOP regimen or R-CHOP combination therapy. L-ASPP with Bortezomib is a viable option for high-risk patients.

Anonymous Patient Answer

What causes precursor t-cell lymphoblastic leukemia-lymphoma?

The specific etiologic factors that elicit PTCL are not readily identified based on epidemiological data, and the vast majority of children with the disease develop the disease by 10 years of age.

Anonymous Patient Answer

How many people get precursor t-cell lymphoblastic leukemia-lymphoma a year in the United States?

Only a very tiny percentage of all diagnosed cases of precursor t-cell lymphoblastic leukemia-lymphoma is diagnosed in children under the age of 19. Given current treatment standards in the United States, the average incidence of PTLL is expected to be about 7 cases per one million population per year.

Anonymous Patient Answer

Can precursor t-cell lymphoblastic leukemia-lymphoma be cured?

In a recent study, findings show that a very high proportion of patients diagnosed with PRALP at an early stage can be cured. In fact, the majority of treated patients with disease at risk can be eradicated. Moreover, even if an aggressive treatment is required, cure is often possible. Based on our results, an intensifying treatment schedule with higher doses is justified.

Anonymous Patient Answer

What are the common side effects of vincristine sulfate?

Very commonly reported common side effects in children treated with vincristine sulfate include thrombocytopenia, leukopenia, and neutropenia. Mild anemia and transient gastrointestinal disturbances are rare. There are rare reports of allergic reactions, most of which were not serious. Long-term surveillance to evaluate for neuro- and/or cardiac toxicity due to vincristine sulfate is recommended.

Anonymous Patient Answer

What is the latest research for precursor t-cell lymphoblastic leukemia-lymphoma?

While the latest research in precursor t-cell lymphoblastic leukemia-lymphoma is promising, there are still gaps to fill as well. It will be the next step in developing a better treatment for this form of cancer. Researchers at the National Cancer Institute will be looking at different parts of the body, including the blood, bone marrow, spleen, and other tissues. This trial should not be too long for patients. Some trials take six to nine months. Patients have only to arrive at the right clinic for treatment in the future. As a precursor t-cell lymphoblastic leukemialymphoma patient, you can expect to start your treatments sooner and be finished sooner once your treatment is administered.

Anonymous Patient Answer

What is the average age someone gets precursor t-cell lymphoblastic leukemia-lymphoma?

Mean age at diagnosis for adolescent cases was 11 years, versus 12 years for adults. This age distribution may reflect changes in the epidemiology of precursor T-cell lymphoblastic leukemia-lymphoma in recent decades.

Anonymous Patient Answer

How does vincristine sulfate work?

In spite of its known cytostatic action and the fact that it is able to interact with a number of different molecular targets, vincristine sulfate can exert a number of other biological effects, including stimulation of angiogenesis, enhancement of mitogenesis, down-regulation of tumor-suppressor genes, and induction of autophagic cell death.

Anonymous Patient Answer

How serious can precursor t-cell lymphoblastic leukemia-lymphoma be?

Patients with PM should be considered for treatment since a significant number will not be responsive to usual treatments or will relapse. The prognosis of patients with PM remains poor with a median survival of only 3 to 6 months with current treatment and a median overall survival of 16, 11, and 8 months with aggressive treatment and hematopoietic stem cell transplantation, intensive chemotherapy, and intensive chemotherapy plus high dose cytarabine, respectively.

Anonymous Patient Answer

Who should consider clinical trials for precursor t-cell lymphoblastic leukemia-lymphoma?

Because endogenous remission of PTCL was exceedingly rare at presentation (only 5 of 1,024 patients), clinical trials may enable survivors to achieve long-term sustained clinical remissions. Clinical trials should target high-risk patients, in order to minimize relapse rates. Larger, more rigorous studies are urgently needed.

Anonymous Patient Answer
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