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Detection of PCM1-JAK2 Fusion Gene by FISH in the Two Types of t-MDS/AML and Relationship Between PCM1-JAK2 Fusion Gene and Cumulative Dose, Dose IntensityNCT03943394

PCM1-JAK2 in Therapy Related Neoplasms

An observational study of Detection of PCM1-JAK2 Fusion Gene by FISH in the Two Types of t-MDS/AML and Relationship Between PCM1-JAK2 Fusion Gene and Cumulative Dose, Dose Intensity, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The term "therapy-related" leukemia is descriptive and is based on a patient's history of exposure to cytotoxic agents. Although a causal relationship is implied, the mechanism remains to be proven. Read more about this study

Who is it for?
Any age
What is being tested?
fresh samples are obtained from patients for detction of PCM1- JAK2 fusion gene
How many people
140 participants
Where
No sites listed yet
Study dates
Jun 2019to Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: therapy related acute myeloid leukemia and / or myelodysplastic syndrome

Who may be able to join

  • • Myelodysplastic syndromes: the diagnosis of MDS must be confirmed by a bone marrow aspirate and/or biopsy : blast count must be < 20%; patients with any International Prognostic Score (IPSS) are eligible; patients with low or intermediate (INT)-1 IPSS must have a platelet count < 50x10⁹/L and/or absolute neutrophil count (ANC) < 50x10⁹/L.
  • Acute myeloid leukemia with multilineage dysplasia: the diagnosis of AML-TLD must be confirmed by a bone marrow aspirate and/or biopsy NOTE: there must be evidence of >= 20% blasts on the review of the bone marrow aspirate and/or biopsy; AML-TLD will be interpreted to include patients formerly diagnosed by French-American-British (FAB) criteria as refractory anemia with excess blasts in transformation (RAEB-t), as well as patients with no history of antecedent hematologic disorder who have AML which meets criteria for AML-TLD by World Health Organization (WHO) criteria; patients with AML-TLD must have a white blood cell (WBC) =< 30x10⁹/L documented within 4 weeks prior to study entry (two sets of counts that are 2 weeks apart will be taken); patients whose WBC has doubled within this period of time and is greater than 20x10⁹/L at the time of screening will not be eligible
  • Patients have started therapy (cytotoxic agents and ionizing radiotherapy) at least 2 years ago.

Who cannot join

  • other therapy related neoplasms other than myelodplastic syndrome or acute myeloid leukemia

About this study

Official title: PCM1-JAK2 Fusion Gene Detection in Patients With Therapy Related Myelodysplastic Syndrome / Acute Myeloid Leukemia Patients

The term "therapy-related" leukemia is descriptive and is based on a patient's history of exposure to cytotoxic agents. Although a causal relationship is implied, the mechanism remains to be proven. These neoplasms are thought to be the direct consequence of mutational events induced by the prior therapy Therapy-related myelodysplastic syndromes / acute myeloid leukemia (t- MDS / t-AML) is now considered a single entity, called therapy-related myeloid neoplasms based on the current World Health Organization WHO classification2,. It is a well-recognized clinical syndrome occurring as a late complication following Cytotoxic agents and ionizing radiotherapy in the treatment of most cancer types: Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), sarcoma, and ovarian and testicular cancerThe incidence of t-MDS/AML following conventional therapy ranges from 0.8% to 6.3% at 20 years. The median time to development of t-MDS/AML is 3 to 5 years, with the risk decreasing markedly after the first decade Two types of t-MDS/AML are recognized in the WHO classification depending on the causative therapeutic exposure: an alkylating agent/radiation-related type and a topoisomerase II inhibitor-related type. Alkylating agent-related t-MDS/AML usually appears 4 to 7 years after exposure to the mutagenic agent .The reciprocal translocation t(8;9) (p22;p24) between the short arm of chromosome 8 and the long arm of chromosome 9 is a recurrent abnormality that fuses the Janus activated kinase 2 (JAK2) to the human autoantigen pericentriolar material 1 gene (PCM1) , with breakage and reunion at bands 8p11 and 9q3410Due to PCM1-JAK2 gene fusion, the coiled-coil domains of PCM1 mediate an oligomerization that brings together the linked JAK2 domains resulting in a constitutively activated tyrosine kinase domain of JAK2The most common mechanism for JAK2 activation in hematologic malignancies is the point mutation at position 617 (V617F).

The consequences of JAK2 activation are neoplastic transformation and abnormal cell proliferation in various malignancies

  • So, translocations involving the JAK2 locus are considered of oncogenic importance in acute leukemias and myelodysplastic/ myeloproliferative diseases.
  • Patients with this abnormality present with broad clinical spectrum ranging from chronic to acute hematological diseases with myeloid or lymphoid appearance
Read the detailed description

The term "therapy-related" leukemia is descriptive and is based on a patient's history of exposure to cytotoxic agents. Although a causal relationship is implied, the mechanism remains to be proven. These neoplasms are thought to be the direct consequence of mutational events induced by the prior therapy .

Therapy-related myelodysplastic syndromes / acute myeloid leukemia (t- MDS / t-AML) is now considered a single entity, called therapy-related myeloid neoplasms based on the current World Health Organization WHO classification2,. It is a well-recognized clinical syndrome occurring as a late complication following Cytotoxic agents and ionizing radiotherapy in the treatment of most cancer types: Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), sarcoma, and ovarian and testicular cancer3,4.

The characteristics of therapy-related myeloid neoplasm and the timing of its development after a primary diagnosis depend on the exposure to specific agents as well as the cumulative dose and dose intensity of the preceding cytotoxic therapy 5.

The incidence of t-MDS/AML following conventional therapy ranges from 0.8% to 6.3% at 20 years. The median time to development of t-MDS/AML is 3 to 5 years, with the risk decreasing markedly after the first decade 6.

Two types of t-MDS/AML are recognized in the WHO classification depending on the causative therapeutic exposure: an alkylating agent/radiation-related type and a topoisomerase II inhibitor-related type. Alkylating agent-related t-MDS/AML usually appears 4 to 7 years after exposure to the mutagenic agent .

Approximately two-thirds of patients present with MDS and the remainder with AML with myelodysplastic features. Patients frequently present with cytopenias. Multilineage dysplasia is often present 7.

In this classic form of therapy-related leukemia that follows treatment with alkylating agents and/or radiation therapy, the blood and bone marrow findings resemble those seen in primary MDS, although the degree of dysgranulopoiesis and dysmegakaryocytopoiesis is typically greater 8.

In contrast to alkylating agent t-MDS/AML, AML secondary to topoisomerase II inhibitors often does not have a preceding myelodysplastic phase, and presents as overt acute leukemia, often with a prominent monocytic component. The latency period between the initiation of treatment with topoisomerase II inhibitors and the onset of leukemia is brief, with a median of 2 to 3 years 9.

The reciprocal translocation t(8;9) (p22;p24) between the short arm of chromosome 8 and the long arm of chromosome 9 is a recurrent abnormality that fuses the Janus activated kinase 2 (JAK2) to the human autoantigen pericentriolar material 1 gene (PCM1) , with breakage and reunion at bands 8p11 and 9q341010.

PCM1 encodes a large protein of 228kDa containing several potential coiled-coil domains in its aminoterminal part. This protein is localized in cytoplasmatic granules referred to as centriolar satellites. It is supposed to play a crucial role in the assembly of centrosomal proteins, microtubule organisation, and in the progression of cell cycle11.

Due to PCM1-JAK2 gene fusion, the coiled-coil domains of PCM1 mediate an oligomerization that brings together the linked JAK2 domains resulting in a constitutively activated tyrosine kinase domain of JAK212, 13.

JAK2 is a member of the Janus family of tyrosine kinases (JAK1, JAK2, JAK3, TYK2). These non-receptor tyrosine kinases play a significant role in various signal transduction pathways that regulate cellular survival, proliferation, differentiation, and apoptosis. The protein is formed of seven domains. The JH2 domain (pseudokinase domain, kinase-like domain) is located in exon 14 and has an essential negative autoregulatory function14.

The most common mechanism for JAK2 activation in hematologic malignancies is the point mutation at position 617 (V617F).

The consequences of JAK2 activation are neoplastic transformation and abnormal cell proliferation in various malignancies15.

  • So, translocations involving the JAK2 locus are considered of oncogenic importance in acute leukemias and myelodysplastic/ myeloproliferative diseases.
  • Patients with this abnormality present with broad clinical spectrum ranging from chronic to acute hematological diseases with myeloid or lymphoid appearance 16.

Fluorescence in situ hybridization (FISH) is a kind of cytogenetic technique that allows the visualization of defined nucleic acid sequences in particular cellular or chromosomal sites by hybridization of complementary fluorescently labeled probe sequences within intact metaphase or interphase cells.

The fluorescent probes are nucleic acid labeled with fluorescent groups and can bind to specific DNA/RNA sequences. Fluorescence microscopy can be used to find out where the fluorescent probe is bound to the chromosomes17.

Being tested
fresh samples are obtained from patients for detction of PCM1- JAK2 fusion gene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fresh samples are obtained from patients for detction of PCM1- JAK2 fusion geneOther

    Samples are dehydrated in ethanol (a 50, 80 and 95% (v/v) series, exposure for 3 min to 300 µl ethanol at each concentration) prior to hybridization.

    Samples on tapes are hybridized for 15 minutes at 55?C using a moisture-sealed slide incubation chamber. Briefly, 500 µl volumes of hybridization buffer (0.7 M NaCl, 0.1 M Tris [pH 8.0], 0.1% sodium dodecyl sulfate, 10 mM EDTA, containing probe, preheated to 55 ºC) are applied to the surface of the tape and the chamber's lid is sealed, creating a moist, temperature controlled environment within the chamber.

    After 15 min, the lid is removed and samples are briefly rinsed with probe-free hybridization buffer, preheated to 55ºC.

    Hybridized cells on tapes are counterstained for 10 minutes in the dark with ~30 µl mounting medium containing 1.5 µg ml-1 4',6-diamidino-2-phenylindole (DAPI).

    Then tapes are mounted with a coverslip and examined using a fluorescence microscope.

Study groups in NCT03943394
Study groupRoleWhat they receive
Denovo MDS/ AMLPatients with de-novo myeloid neoplasm either myelodysplastic syndrome and/ or acute myeloid leukemia which are diagnosed by complete blood count , blood film, bone marrow aspirate, bone marrow biopsy , immunophenotyping and bone marrow biopsy with these inclusion criteria • Myelodysplastic syndromes: the diagnosis of MDS must be confirmed by a bone marrow aspirate and/or biopsy : blast count must be < 20%; • Acute myeloid leukemia with multilineage dysplasia: the diagnosis of AML-TLD must be confirmed by a bone marrow aspirate and/or biopsy NOTE: there must be evidence of >= 20% blasts on the review of the bone marrow aspirate and/or biopsy;
Receives: Other: fresh samples are obtained from patients for detction of PCM1- JAK2 fusion gene
therapy related MDS/ AMLPCM1-JAK2 fusion gene detection in patients with therapy related Myelodysplastic syndrome / Acute myeloid leukemia patients
Receives: Other: fresh samples are obtained from patients for detction of PCM1- JAK2 fusion gene

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection of PCM1-JAK2fusion gene

    Using fresh sample from patients with myeloid neoplasm to search for PCM1-JAK2 fusion gene in the 2 types of thaerap related myeloid neoplasm , studying relationship between PCM1-JAK2 and dose intensity and time of exposure, and studying relationship between PCM1-JAK2 and other cytogenetic abnormalities by using FISH technique and

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study startJun 2019 (estimated)
  3. Primary completionJun 2021 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03943394
Sponsor's protocol ID
PCM1-JAK2 fusion gene
Status last verified
May 2019
First submitted
7 May 2019
Last updated
9 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Detection of PCM1-JAK2 Fusion Gene by FISH in the Two Types of t-MDS/AML and Relationship Between PCM1-JAK2 Fusion Gene and Cumulative Dose, Dose Intensity, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of PCM1-JAK2fusion gene (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.

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