Filgrastim-sndz for Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma+12 More
Filgrastim-sndz - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of tagraxofusp and chemotherapy can improve the outcome of patients with CD123 positive acute lymphoblastic leukemia or lymphoblastic lymphoma.

See full description

Eligible Conditions

  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Lymphoblastic lymphoma (Precursor T-lymphoblastic lymphoma/leukemia) refractory
  • Refractory T Acute Lymphoblastic Leukemia
  • Recurrent B Acute Lymphoblastic Leukemia
  • Refractory B Acute Lymphoblastic Leukemia
  • Recurrent T Acute Lymphoblastic Leukemia

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Filgrastim-sndz will improve 2 primary outcomes and 4 secondary outcomes in patients with Precursor T-Cell Lymphoblastic Leukemia-Lymphoma. Measurement will happen over the course of Up to 30 days after last dose.

Year 3
Relapsed-free survival (RFS)
Up to 3 years
Overall survival
Day 30
Incidence of drug-related grade 3/4/5 adverse events
Day 28
Complete response
Maximum tolerated dose
Overall response rate

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Treatment (tagraxofusp, chemotherapy)
1 of 1
Experimental Treatment

This trial requires 40 total participants across 1 different treatment group

This trial involves a single treatment. Filgrastim-sndz 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 1 & 2 and have already been tested with other people.

Treatment (tagraxofusp, chemotherapy)See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
FDA approved
Cortisone
Not yet FDA approved
Leucovorin
FDA approved
Coenzyme M
FDA approved
Methotrexate
FDA approved
Filgrastim
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved
Dexamethasone
FDA approved
Vincristine
FDA approved
Rituximab
FDA approved
Mercaptopurine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Precursor T-Cell Lymphoblastic Leukemia-Lymphoma or one of the other 12 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Alanine aminotransferase (ALT) is less than or equal to 2.5 times the upper limit of the normal range unless due to disease involvement of the liver or hemolysis, in which case an ALT is less than or equal to 10 times the upper limit of the normal range is acceptable. show original
"Patients who are able to have children must use a form of birth control for four months after their treatment is over. show original
As long as a patient's total serum bilirubin level is less than 1.5 times the upper limit of normal and their direct bilirubin level is less than 2 times the upper limit of normal, they are eligible for the study. show original
The serum creatinine level is less than 1.5 mg/dL. show original
People between the ages of 18 and 70 who have relapsed/refractory ALL or lymphoblastic lymphoma, and who test positive for CD123 may have their diagnosis confirmed using either flow cytometry or immunohistochemistry. show original
Serum albumin >= 3.2 g/dL (32 g/L). Albumin infusions are not permitted in order to enable eligibility
This person has a very poor performance status and is not likely to survive long. show original
Aspartate aminotransferase (AST) is less than 2.5 times the upper limit of normal (ULN), unless due to disease involvement of the liver or hemolysis, in which case an alanine aminotransferase (ALT) is less than 10 times the ULN is acceptable. show original
Women of childbearing potential must have a negative pregnancy test before starting treatment. show original
Signed informed consent

Patient Q&A Section

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

"The most common treatments used In a recent study were chemotherapy and peripheral blood stem cell transplantation. In cases where multicentric disease was present, surgery or radiation therapy were also used. When a patient had multiple sites of disease, the order of treatment varied according to the degree of involvement at each site. For all patients, the first line regimen consisted of prednisone plus methotrexate, followed by six weeks of cytarabine." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of pegfilgrastim?

"Pegfilgrastim therapy was well tolerated In a recent study population; however, common adverse events included infection (56%), infusion-related reactions (49%) and fever (37%); most occurred during the first 6 weeks of therapy. No serious infectious complications were reported. Serious infections were found in <1% of patients who received pegfilgrastim. The incidence of serious infusion-related reactions was higher in infants than in adults, but no differences between genders were observed." - Anonymous Online Contributor

Unverified Answer

What is pegfilgrastim?

"Pegfilgrastim is a growth factor produced by a bacterial species, Bacillus cereus strain ATCC 14579, which is used as an anticancer drug. The FDA approved pegfilgrastim for use in adults and children with chemotherapy-induced neutropenia. Because of its unique structure, pegylated filgrastim offers a number of advantages over conventional filgrastim such as improved bioavailability, reduced frequency and severity of adverse events, lower cost and elimination of the need for regular filgrastim dosing. In addition, pegfilgrastim presents a low risk of infusion-related reactions compared with filgrastim." - Anonymous Online Contributor

Unverified Answer

Has pegfilgrastim proven to be more effective than a placebo?

"Pegfilgrastim showed the same efficacy as a control in preventing febrile neutropenia with a higher incidence of infection when compared to placebo. This result suggests that pegfilgrastim cannot be recommended for this indication." - Anonymous Online Contributor

Unverified Answer

What is precursor t-cell lymphoblastic leukemia-lymphoma?

"Findings from a recent study shows that a CD5+CD19+ T-LBL proband has a unique genetic profile, indicating that there may be different disease pathways among these cases. We suggest that this study may provide new insights into the pathogenesis of the disease along with its critical implication for future diagnosis and treatment." - Anonymous Online Contributor

Unverified Answer

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

"Between 1995 and 2003, the number of new cases per year increased more than three-fold from 5.0 to 16.4 for PTCLL. Many children diagnosed with PTCLL were young (median age 10 years) and were hospitalized. The proportion of PTCLL patients who underwent allogeneic hematopoietic stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)ation was low; however, the survival rates after HSCT were excellent. The incidence of PTCLL declined after 2000, probably because of reductions in drug exposure and rising awareness among physicians." - Anonymous Online Contributor

Unverified Answer

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

"The average age at diagnosis for PTLL/T-PLL is 46 years (range 10-79 years). PTLL/T-PLL has been reported in individuals up to 79 years old. Most cases occur in adults or adolescents; however, PTLL/T-PLL can arise in children under the age of 10 years. The presentation of this disease is variable. Symptoms are typically nonspecific. Abnormal findings on an individual's examination may include enlargement of one or more lymph nodes, enlarged spleen, paracentesis, elevated creatinine, bone marrow involvement, bone lesions, and hepatomegaly." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pegfilgrastim?

"The percentage of patients who had received pegfilgrastim prior to participation in the current trial was approximately 50%. Because the majority of these patients were treated as outpatients at the study center, it is possible that more suboptimal doses of pegfilgrastim could have been used in the study population compared with actual use in hospitalized patients. The available data suggest that pegfilgrastim reduces the number of febrile neutropenic episodes in children with acute lymphocytic leukemia when given at a dose of 40 microg/kg per day. In addition, pegfilgrastim is effective when used for prophylaxis in children with moderate to severe chronic myelogenous leukemia who are receiving maintenance therapy." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for precursor t-cell lymphoblastic leukemia-lymphoma?

"Survival rates are improving due to advances in the treatment of precursor T-cell lymphoblastic leukemia-lymphoma. In addition, the current FIGO staging system is influencing survival outcomes for patients with this cancer." - Anonymous Online Contributor

Unverified Answer

How quickly does precursor t-cell lymphoblastic leukemia-lymphoma spread?

"It is likely that PTCLL was introduced into Europe around 2000 through immigration from South America. Over the last decade we observed a significant increase in the number of patients diagnosed with PTCLL. This finding was accompanied by an increase in the number of countries reporting new cases of PTCLL. There is a need for national data collection to monitor and estimate trends in PTCLL incidence and diagnose more cases to provide evidence on its epidemiology and management." - Anonymous Online Contributor

Unverified Answer

Is pegfilgrastim typically used in combination with any other treatments?

"The use of pegfilgrastim in combination with chemotherapy and radiotherapy is not common. Therefore, we recommend obtaining formal approval for all patients before starting pegfilgrastim therapy." - Anonymous Online Contributor

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