Filgrastim for Hematologic Neoplasms

Phase-Based Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
Hematologic Neoplasms+1 More
Filgrastim - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hematologic Neoplasms

Study Summary

This study is evaluating whether a specific type of donor may help reduce the risk of cancer recurring after transplant.

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Eligible Conditions

  • Hematologic Neoplasms
  • Malignancies, Hematologic

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Filgrastim will improve 1 primary outcome in patients with Hematologic Neoplasms. Measurement will happen over the course of 1 year.

1 year
proportion of patients undergoing an allo HCT transplant who have a KIR favorable donor.

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Patients will undergo donor/recipient bone marrow

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. Filgrastim is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Patients will undergo donor/recipient bone marrowAll patients will undergo haploidentical, allogeneic hematopoietic cell transplantation. Conditioning will consist of fludarabine, melphalan, and thiotepa. Graft versus host disease prophylaxis will be with post-transplant cyclophosphamide in addition to standard tacrolimus and mycophenolate mofetil. Donors will undergo HLA and KIR geno- and allotyping to determine the best donor.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Mycophenolate mofetil
FDA approved
Coenzyme M
FDA approved
Melphalan
FDA approved
Cyclophosphamide
FDA approved
Thiotepa
FDA approved
Filgrastim
FDA approved
Tacrolimus
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Hematologic Neoplasms or the other condition 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:
t(9;22) or detected BCR-ABL1 translocation by genomic methodologies
BCR-ABL1-Like B-ALL [54] including mutations of IKZF1 or CRLF2
Translocations or mutations involving 11q23 (MLL) gene.
Hypodiploid karyotype
Deletion of 9p
Loss of 17p or TP53 mutation
T-lymphocyte lineage antigen expression (T-ALL)
CNS or other extramedullary involvement
WBC count >/= 100,000 cells/μL at diagnosis
Relapsed ALL, biphenotypic/bilineal leukemia, or AML with </= 10% blasts in the bone marrow prior to transplantation

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 hematologic neoplasms?

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Hematologic neoplasms are a group of cancer types involving blood-forming tissue that are frequently caused by genetic inheritance, exposure to ionizing radiation or to environmental toxins (e.g., medications), or a combination thereof. Hematologic neoplasms include benign hemoproliferative disorders, hematologic malignancies, and blood disorders with hemolysis, such as aplastic anemia and hemolytic anemias, among others. Hematologic Neoplasms-Cancer and Hematologic Neoplasms-Blood Disorders category is used in the CSC classification. For the most part, the current WHO classification is still used in the classification of leukemias, HLH and Lymphomas.

Unverified Answer

What are the signs of hematologic neoplasms?

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Hematologic lesions in adults cause many of the same signs and symptoms as those of more well defined lesions in children. The differential diagnosis of hematologic lesions depends on the sites that are involved by the neoplasms. The exact presentation and natural history of each hematologic lesion is determined by its anatomic site of appearance, specific pathologic processes, and distribution of affected cells.

Unverified Answer

What are common treatments for hematologic neoplasms?

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Treatment for hematologic neoplasms varies depending on the type of tumor. The treatment may use combinations of different approaches. Combining treatments is preferable to monotherapy in some types of leukemia or in cases of aggressive treatment of aplastic anemia. Treatment-related bone marrow depletion is an example of a complication that is common in patients who suffer from hematologic neoplasms.

Unverified Answer

How many people get hematologic neoplasms a year in the United States?

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There are approximately 1,600 new diagnoses of acute myeloid leukemia, 1,550 of hairy cell leukemia, 800 of chronic myelogenous leukemia a year in the US. The incidence of Langerhans cell histiocytosis is about 1,300 per year. Non-Hodgkin lymphoma incidence in the US is approximately 5,500 per year. Acute lymphoblastic leukemia of childhood is approximately 500 per year. Chronic lymphocytic leukemia of childhood is about 75 per year. Hodgkin disease of childhood is approximately 500 per year. The number of new diagnoses of acute myelogenous leukemia in the US has been stable over the past decade.

Unverified Answer

What causes hematologic neoplasms?

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Aspiration of contaminated thymus or bone marrow may cause hematologic neoplasms. The exact risk from contaminated thymus depends on the patient's age. In children this risk is greater than in adults, but in both groups, the disease occurs at earlier stages. Blood cells are not necessary for the development of hematologic neoplasms, and it appears that many hematologic neoplasms are asymptomatic early in life, with symptoms developing later in life.

Unverified Answer

Can hematologic neoplasms be cured?

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Hematological malignancies can be cured only in relatively rare cases that are cured by a combination of radiotherapy, chemotherapy, or hematopoietic stem-cell transplantation. Other types of malignancies do not appear to be curable according to the current clinical data.

Unverified Answer

What are the chances of developing hematologic neoplasms?

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The following variables, including age, sex, blood type, and presence of a family history, were associated with an increased risk of developing hematologic malignancies: leukemia, lymphoma, or multiple myeloma.

Unverified Answer

Is filgrastim typically used in combination with any other treatments?

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There are many options for filgrastim treatment combinations. Filgrastim treatment may be given on its own, with other intravenous antibiotics in cases of infections, with cytotoxic chemotherapeutic agents, or with other stem cell support. Filgrastim is often combined with granulocyte colony-stimulating factor in treatment plans.

Unverified Answer

What are the common side effects of filgrastim?

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Filgrastim has few common side effects, and these can be managed by decreasing the infusion rate, by delaying the start of infusion if side effects are present, or by holding infusion until the side effects subside. It is important to be aware of these common side effects of filgrastim and to consult a treatment-specific list. For a complete list of serious or otherwise side effects, see Filgrastim Side Effects.

Unverified Answer

Does filgrastim improve quality of life for those with hematologic neoplasms?

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Filgrastim improved appetite, mood, and social interaction in patients with hematologic neoplasms. Filgrastim increased caloric intake and may have helped preserve patients' psychosocial and physical quality of life.

Unverified Answer

What is the survival rate for hematologic neoplasms?

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Most patients with hematologic cancers have a poor prognosis, and patients diagnosed in an academic center have worse results than patients in less fortunate settings. Some patients with hematologic malignancies may be candidates for future trials.

Unverified Answer

What is the primary cause of hematologic neoplasms?

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This large cohort study of Canadian patients with hematological malignancies indicates that the most common secondary diagnosis of disease was HIV infection in a proportion of cases, which suggests a causal relationship between the two.

Unverified Answer
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