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Hematologic NeoplasmsPhase 2NCT01374841

Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors

A Phase 2 study testing Cyclophosphamide and Hematopoietic Stem Cell Transplantation, in people with Hematologic Neoplasms, run by European Institute of Oncology at 1 site in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 purpose of this study is to determine if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative transplant with peripheral stem cells from Human Leukocyte Antigen (HLA) haploidentical donors with pre and post-transplant cyclophosphamide as… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hematologic Neoplasms
What is being tested?
Cyclophosphamide and Hematopoietic Stem Cell Transplantation,
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
Aug 2010to Dec 2023
Phase
Phase 2
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≤70 years old
  • Eligible diagnoses:
  • CML in AP
  • AML with high-risk cytogenetics [del(5q)/-5, del(7q)/-7, abnormal 3q, 9q, 11q, 20q, 21q, 17p, t(6:9), t(9;22), complex karyotypes (≥3 abnormalities)] in CR1
  • AML ≥ CR2; patients should have <5% marrow blasts at the time of transplant
  • High-risk ALL defined as:
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  • CR1 with high-risk cytogenetics t(9;22), t(8;14), t(4;11), t(1;19) for adult patients >4 wk to achieve CR1
  • ≥ CR2 Patients should have <5% marrow blasts at the time of transplant
  • MDS (>int-1 per IPSS) after ≥ 1 prior cycle of induction chemotherapy; should have<5% marrow blasts at the time of transplant
  • MM Stage II or III patients who have progressed after an initial response to chemotherapy or autologous HSCT or MM patients with refractory disease who may benefit from tandem autologous-nonmyeloablative allogeneic transplant
  • CLL, NHL or HD who are ineligible for autologous HSCT or who have resistant/refractory disease and who may benefit from tandem autologous nonmyeloablative allogeneic transplant.
  • Patients who have received a prior allogeneic HSCT and who have either rejected their grafts or who have become tolerant of their grafts with no active GvHD requiring immunosuppressive therapy could be enrolled

Who cannot join

  • Patients with suitably matched related or unrelated donors
  • Patients with conventional transplant options (a conventional transplant should be the priority for eligible patients ≤ 50 yr of age who have a related donor mismatched for a single HLA-A, -B or DRB1 antigen)
  • CNS involvement with disease refractory to intrathecal chemotherapy
  • Presence of active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis, tuberculosis)
  • Karnofsky Performance Status < 60% for adult patients (Appendix A)
  • Patients with the following organ dysfunction:
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  • Left ventricular ejection fraction <35%
  • DLCO <35% and/or receiving supplemental continuous oxygen
  • Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL or symptomatic biliary disease.
  • HIV-positive patients
  • Women of childbearing potential who are pregnant (β-HCG+) or breast feeding
  • Fertile men and women unwilling to use contraceptives during and for 12 months post transplant
  • Life expectancy severely limited by diseases other than malignancy
  • Patients on any other investigational drug at time of enrolment

Trial locations and contacts

1 site in 1 country.

Rocco Pastano, MD contact

rocco.pastano@ieo.it

Italy1 site, 1 recruiting

  • European Institute of Oncology

    Milan, 20141

    Rocco Pastano, MD, +390257489538, rocco.pastano@ieo.it

    Rocco Pastano, MD

    Recruiting

Other trials in Italy

About this study

Official title: Nonmyeloablative Hematopoietic Stem Cell Transplantation (SCT) for High-Risk Hematologic Malignancies With Related, HLA-Haploidentical Donors: A Phase II Trial of Immunosuppression With Cyclophosphamide Administered Before and After SCT

The purpose of this study is to determine if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative transplant with peripheral stem cells from Human Leukocyte Antigen (HLA) haploidentical donors with pre and post-transplant cyclophosphamide as immunosuppression.

Read the detailed description

It is important to extend the option of nonmyeloablative, hematopoietic stem cell transplantation (HSCT) for potential therapy of hematologic malignancies to patients who do not have an HLA-matched donor. Almost all patients would have a related donor identical for one HLA haplotype (haploidentical) and mismatched at HLA-A, B or DR of the unshared haplotype. Thus far, nonmyeloablative HSCT from HLA-mismatched donors has been associated with a high rate of graft failure and graft-versus-host disease (GVHD). In this protocol, we will use a combination of immunosuppressive agents including cyclophosphamide administered before and after HSCT to facilitate engraftment and to delete highly alloreactive T-cell clones presumably involved in GVHD.

Being tested
Cyclophosphamide, Hematopoietic Stem Cell Transplantation,
Keywords
Hematopoietic Stem Cell Transplantation, High-Risk Hematologic Neoplasms, Haploidentical Donors, Cyclophosphamide
Medical subject headings
Hematologic Neoplasms

What participants receive

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

  • CyclophosphamideDrug

    Also called Endoxan

    14.5 mg/kg, IV qd on day -6 and -5 and 50 mg/kg, IV on day +3 and +4

  • Hematopoietic Stem Cell Transplantation,Other

    Also called Stem cell transplantation

    Hematopoietic Stem Cell Transplantation,

Study groups in NCT01374841
Study groupRoleWhat they receive
Stem Cell Transplant+CyclophosphamideExperimentalpatients with high-risk hematologic malignancies will receive hematopoietic stem cell transplantation from haploidentical donors after treatment with cyclophosphamide
Receives: Drug: Cyclophosphamide; Other: Hematopoietic Stem Cell Transplantation,

What is being measured

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

  1. Donor engraftment

    percentage of donor engraftment after 84 from baseline

    Measured: Day +84

Secondary outcomes (2)

  1. Incidence and severity of graft versus host disease

    Incidence and severity of graft versus host disease after 200 days from the baseline

    Measured: up to 200 days after the baseline

  2. Non-relapse-related mortality

    incidence of non-relapse-related mortality after 200 days from the baseline

    Measured: Incidence and severity of graft versus host disease after 200 days from the baseline

Timeline

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

  1. First posted16 Jun 2011 (estimated)
  2. Study startAug 2010
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01374841
Sponsor's protocol ID
IEO S513/110
Other IDs
2009-018083-94, 2009
Status last verified
Jun 2023
First submitted
15 Jun 2011
Last updated
28 Jun 2023
Results posted
No
Data monitoring committee
No

Publications

  • Luznik L, Jalla S, Engstrom LW, Iannone R, Fuchs EJ. Durable engraftment of major histocompatibility complex-incompatible cells after nonmyeloablative conditioning with fludarabine, low-dose total body irradiation, and posttransplantation cyclophosphamide. Blood. 2001 Dec 1;98(12):3456-64. doi: 10.1182/blood.v98.12.3456.

    PubMed 11719388

  • O'Donnell PV, Luznik L, Jones RJ, Vogelsang GB, Leffell MS, Phelps M, Rhubart P, Cowan K, Piantados S, Fuchs EJ. Nonmyeloablative bone marrow transplantation from partially HLA-mismatched related donors using posttransplantation cyclophosphamide. Biol Blood Marrow Transplant. 2002;8(7):377-86. doi: 10.1053/bbmt.2002.v8.pm12171484.

    PubMed 12171484

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide and Hematopoietic Stem Cell Transplantation, in people with Hematologic Neoplasms, run by European Institute of Oncology at 1 site in Italy.

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 12 inclusion and 14 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Rocco Pastano, MD (rocco.pastano@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Donor engraftment (time frame: Day +84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01374841, which also lists 2 linked publications.

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 28 Jun 2023.

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