Nonmyeloablative Allogeneic Transplant (Mini-allo)

November 21, 2022 updated by: Scripps Health

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation

Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

same

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > 55 years or
  2. Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min
  3. Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
  4. Caregiver must be available while outpatient

Guidelines for Cladribine-Melphalan-based conditioning:

  • Bone Marrow Failure States Severe Aplastic Anemia (relapsed following immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic features or hemosiderosis)
  • AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second induction attempt)
  • ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse failing reinduction attempt)
  • MDS (RAEB, RAEBiT, CMMoL)
  • CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy
  • Hodgkin's lymphoma (first or greater relapse)
  • Non-Hodgkin's Lymphoma
  • Aggressive Histology (includes T Cell NHL) Incomplete response to induction Second CR Sensitive or refractory relapse
  • Indolent Histology Second or greater relapse
  • Mantle Cell Lymphoma (any Stage - must have received induction chemotherapy)
  • Multiple Myeloma (10% residual plasmacytosis following anthracycline-based chemotherapy or residual disease following autologous transplant)
  • Waldenstrom Macroglobulinemia (must have failed either purine analogue-based chemotherapy (Fludara or 2CdA) or standard CVP therapy; hyperviscosity or cytopenias)

Guidelines for total lymphoid irradiation-based conditioning

  • MDS (RA, RARS)
  • CLL (Rai stage III or IV - must have received at least two different treatment regimens in the past)
  • Breast Cancer (symptomatic metastatic disease, who have failed standard chemotherapy)
  • Renal Cell Cancer (metastatic disease at multiple sites)
  • Malignant Melanoma (metastatic disease at multiple sites)
  • Sarcoma (all subtypes presently, unresectable metastatic disease)
  • Ovarian Cancer (stage III or IV, platinum insensitive disease, i.e. progression within 6 months of initial platinum chemotherapy)
  • Thymoma (unresectable disease)

Exclusion Criteria:

  1. Prior allogeneic stem cell or bone marrow transplant
  2. Current or past history of invasive mycotic infection
  3. Breast Feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Cladribine + melphalan
Cladribine + melphalan conditioning
Procedure: Nonmyeloablative Allogeneic Transplant
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
Procedure: Nonmyeloablative Allogeneic Transplant
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)
Other: TLI
Total lymphoid irradiation conditioning
Procedure: Nonmyeloablative Allogeneic Transplant
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
Procedure: Nonmyeloablative Allogeneic Transplant
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Engraftment
Time Frame: One year
Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.
One year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Graft-versus-host disease
Time Frame: One year
Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Scripps Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey W. Andrey, M.D., Scripps Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB#13-6255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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